Bile Duct Cancer

EA2187



Testing the Combination of Pevonedistat with Chemotherapy for Bile Duct Cancer of the Liver

STATUS: Temporarily Closed to Accrual


This phase II trial studies how well pevonedistat alone or in combination with chemotherapy (paclitaxel and carboplatin) works in treating patients with bile duct cancer of the liver. Pevonedistat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This study may help the study doctors find out how well pevonedistat shrinks bile duct cancer of the liver when given alone and when in combination with paclitaxel and carboplatin.
  • Patient must be >= 18 years of age

  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1

  • Patient must have a life expectancy >= 12 weeks

  • Patient must have histologically confirmed intrahepatic cholangiocarcinoma or biphasic hepatocellular carcinoma and cholangiocarcinoma that is metastatic or unresectable and who have progressed on or been intolerant of one prior line of systemic gemcitabine containing chemotherapy regimen. * NOTE: Prior immunotherapy or targeted therapies are allowed and will not be considered a line of therapy unless administered with cytotoxic chemotherapy

  • Patient must have measurable disease. For patients who have received localized therapy (embolization, chemoembolization, radiofrequency ablation or radiation) are eligible if measurable disease is not within the treatment field or the treated disease has clearly progressed since last localized therapy

  • Patients must not have had major surgery within 14 days before randomization. Patients with surgery planned during study period are ineligible

  • Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and until at least 4 months after the last dose of study treatment. All females of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

  • Women of childbearing potential and sexually active males must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study and continue for at least 4 months after the last dose of protocol treatment

  • Male patients must not donate sperm during the course of this study or within 4 months after receiving their last dose of protocol treatment

  • Female patients must not donate eggs (ova) during the course of this study or within 4 months after receiving their last dose of protocol treatment

  • Leukocytes >= 3,000/mcL (obtained within 14 days prior to randomization)

  • Absolute neutrophil count >= 1,500/mcL (obtained within 14 days prior to randomization)

  • Platelets >= 100,000/mcL (obtained within 14 days prior to randomization)

  • Total bilirubin =< institutional upper limit of normal (ULN) except in patients with Gilbertโ€™s syndrome. Patients with Gilbertโ€™s syndrome may enroll if direct bilirubin =< 1.5 x ULN of the direct bilirubin (obtained within 14 days prior to randomization)

  • Hemoglobin >= 9 g/dL (obtained within 14 days prior to randomization)

  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x institutional ULN (obtained within 14 days prior to randomization)

  • Creatinine =< institutional ULN, OR glomerular filtration rate (GFR) >= 40 mL/min/1.73 m^2 (obtained within 14 days prior to randomization)

  • Patient must not have a prolonged rate corrected QT (QTc) interval >= 480 msec calculated according to institutional guideline

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. Known HIV positive patients who meet the following criteria will be considered eligible: * CD4 count >= 350 cells/mm^3 * Undetectable viral load * Maintained on modern therapeutic regimens utilizing non-CYP interactive agents (i.e. excluding ritonavir) * No history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections

  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

  • Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e. have residual toxicities > grade 1) are ineligible with the exception of alopecia

  • Patients with persistent >= grade 2 diarrhea lasting more than 3 days within 14 weeks of randomization are ineligible

  • Patients who received prior platinum or taxane chemotherapy are eligible

  • Patients with known central nervous system (CNS) involvement are ineligible

  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better. In addition, patients with any of the known cardiopulmonary disease, defined as follows, would be ineligible for this trial: * Unstable angina * Congestive heart failure (New York Heart Association [NYHA] class III or IV;); * Myocardial infarction within 6 months prior to randomization (patients who had ischemic heart disease such as acute coronary syndrome [ACS], myocardial infarction, and/or revascularization greater than 6 months before randomization and who are without cardiac symptoms may enroll) * Symptomatic cardiomyopathy * Clinically symptomatic pulmonary hypertension requiring pharmacologic therapy * Clinically significant arrhythmia, defined as: ** History of polymorphic ventricular fibrillation or torsade de pointes, ** Permanent atrial fibrillation, defined as continuous atrial fibrillation for >= 6 months, ** Persistent atrial fibrillation, defined as sustained atrial fibrillation lasting > 7 days and/or requiring cardioversion in the 4 weeks before randomization, ** Grade 3 atrial fibrillation defined as symptomatic and incompletely controlled medically, or controlled with device (e.g., pacemaker), or ablation ** Patients with paroxysmal atrial fibrillation or grade < 3 atrial fibrillation for period of at least 6 months are permitted to enroll provided that their rate is controlled on a stable regimen

  • Patients must not be receiving any other investigational agents

  • Patients must not have received chemotherapy or radiotherapy within 2 weeks prior to randomization. Prior treatment with radiation therapy involving >= 25% of hematopoietically active bone marrow will be ineligible

  • Patients must not have received immunotherapy within 8 weeks prior to randomization

  • Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to pevonedistat, carboplatin, or paclitaxel

  • Patient must not be receiving any treatment with clinically significant metabolic enzyme inducers within 14 days before the first dose of the study drug as below. Clinically significant metabolic enzyme inducers are not permitted during the study. Patients must not be receiving any medications or substances that are strong inducers of CYP3A4/5 (i.e. phenytoin, rifampin, St. Johns wort) or inhibitors of breast cancer resistance protein (BCRP) (i.e. cyclosporine). Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if a new medication need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product. Inhibitors of CYP3A4/5 are allowed

  • Patients must not have uncontrolled intercurrent illness

  • Patients must not have uncontrolled coagulopathy or bleeding disorder

  • Patients must not have active, uncontrolled infection or severe infectious disease such as severe pneumonia, meningitis, or septicemia

  • Patients with known moderate chronic obstructive pulmonary disease, interstitial lung disease, and pulmonary fibrosis are ineligible

  • Patients must not have psychiatric illness/social situations that would limit compliance with study requirements

  • Patients must have the ability to understand and the willingness to sign a written informed consent document

  • Participants with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible

  • Participants must not have had prior pevonedistat treatment

United States
AK
Anchorage
Alaska Breast Care and Surgery LLC
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Alaska Oncology and Hematology LLC
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Alaska Women's Cancer Care
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Anchorage Associates in Radiation Medicine
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Anchorage Oncology Centre
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Anchorage Radiation Therapy Center
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Email: AKPAMC.OncologyResearchSupport@providence.org

Katmai Oncology Group
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Email: AKPAMC.OncologyResearchSupport@providence.org

Providence Alaska Medical Center
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Email: AKPAMC.OncologyResearchSupport@providence.org

AR
Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
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Email: ResearchInstituteInquiries@CommonSpirit.org

AZ
Kingman
Kingman Regional Medical Center
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Email: research@sncrf.org

Phoenix
Cancer Center at Saint Joseph's
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Email: CancerInstitute@DignityHealth.org

CA
Arroyo Grande
Mission Hope Medical Oncology - Arroyo Grande
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Email: ResearchInstituteInquiries@CommonSpirit.org

PCR Oncology
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Email: research@sncrf.org

Auburn
Sutter Auburn Faith Hospital
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Email: Melanie.Cook@sutterhealth.org

Sutter Cancer Centers Radiation Oncology Services-Auburn
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Email: Melanie.Cook@sutterhealth.org

Berkeley
Alta Bates Summit Medical Center-Herrick Campus
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Email: Melanie.Cook@sutterhealth.org

Burbank
Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Email: Najee.Boucher@providence.org

Cameron Park
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
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Castro Valley
Eden Hospital Medical Center
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Davis
Sutter Davis Hospital
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Duarte
City of Hope Comprehensive Cancer Center
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Email: becomingapatient@coh.org

Fremont
Palo Alto Medical Foundation-Fremont
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Modesto
Memorial Medical Center
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Mountain View
Palo Alto Medical Foundation-Camino Division
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Email: Melanie.Cook@sutterhealth.org

Palo Alto Medical Foundation-Gynecologic Oncology
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Palo Alto
Palo Alto Medical Foundation Health Care
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Roseville
Sutter Cancer Centers Radiation Oncology Services-Roseville
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Sutter Roseville Medical Center
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Sacramento
Sutter Medical Center Sacramento
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San Francisco
California Pacific Medical Center-Pacific Campus
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San Mateo
Mills Health Center
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Email: ctsucontact@westat.com

Santa Cruz
Palo Alto Medical Foundation-Santa Cruz
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Email: hempell@sutterhealth.org

Santa Maria
Mission Hope Medical Oncology - Santa Maria
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Santa Rosa
Sutter Pacific Medical Foundation
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Email: hempell@sutterhealth.org

Sunnyvale
Palo Alto Medical Foundation-Sunnyvale
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Email: hempell@sutterhealth.org

Vacaville
Sutter Cancer Centers Radiation Oncology Services-Vacaville
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Email: hempell@sutterhealth.org

Vallejo
Sutter Solano Medical Center/Cancer Center
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Email: Melanie.Cook@sutterhealth.org

CO
Colorado Springs
Memorial Hospital North
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Penrose-Saint Francis Healthcare
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Email: ResearchTracking@Centura.Org

Rocky Mountain Cancer Centers-Penrose
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Email: ResearchTracking@Centura.Org

UCHealth Memorial Hospital Central
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Denver
Porter Adventist Hospital
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Durango
Mercy Medical Center
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Southwest Oncology PC
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Fort Collins
Cancer Care and Hematology-Fort Collins
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Email: ecog.rss@jimmy.harvard.edu

Poudre Valley Hospital
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Greeley
UCHealth Greeley Hospital
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Email: ecog.rss@jimmy.harvard.edu

Lakewood
Saint Anthony Hospital
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Email: ResearchTracking@Centura.Org

Littleton
Littleton Adventist Hospital
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Email: ResearchTracking@Centura.Org

Longmont
Longmont United Hospital
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Rocky Mountain Cancer Centers-Longmont
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Loveland
Medical Center of the Rockies
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Parker
Parker Adventist Hospital
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Email: ResearchTracking@Centura.Org

Pueblo
Saint Mary Corwin Medical Center
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Email: ResearchTracking@Centura.Org

FL
Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
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Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Fort Lauderdale
Holy Cross Hospital
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Miami
UM Sylvester Comprehensive Cancer Center at Kendall
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University of Miami Miller School of Medicine-Sylvester Cancer Center
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Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
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HI
Aiea
Hawaii Cancer Care - Savio
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Email: info@hawaiicancercare.com

Pali Momi Medical Center
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Queen's Cancer Center - Pearlridge
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The Cancer Center of Hawaii-Pali Momi
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Honolulu
Hawaii Cancer Care Inc - Waterfront Plaza
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Email: i.webster@hawaiicancercare.com

Hawaii Cancer Care Inc-Liliha
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Island Urology
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Email: virginia@cc.hawaii.edu

Kapiolani Medical Center for Women and Children
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Kuakini Medical Center
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Queen's Cancer Cenrer - POB I
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Queen's Cancer Center - Kuakini
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Queen's Medical Center
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Straub Clinic and Hospital
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The Cancer Center of Hawaii-Liliha
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University of Hawaii Cancer Center
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Lihue
Wilcox Memorial Hospital and Kauai Medical Clinic
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IA
Ames
Mary Greeley Medical Center
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McFarland Clinic PC - Ames
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Email: ksoder@mcfarlandclinic.com

Boone
McFarland Clinic PC-Boone
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Clive
Medical Oncology and Hematology Associates-West Des Moines
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Mercy Cancer Center-West Lakes
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Email: cancerresearch@mercydesmoines.org

Council Bluffs
Alegent Health Mercy Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org

Creston
Greater Regional Medical Center
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Email: cancerresearch@mercydesmoines.org

Des Moines
Broadlawns Medical Center
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Iowa Lutheran Hospital
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Iowa Methodist Medical Center
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Medical Oncology and Hematology Associates-Des Moines
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Mercy Medical Center - Des Moines
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Email: cancerresearch@mercydesmoines.org

Mission Cancer and Blood - Laurel
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Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
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Trinity Regional Medical Center
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Jefferson
McFarland Clinic PC-Jefferson
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Marshalltown
McFarland Clinic PC-Marshalltown
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West Des Moines
Mercy Medical Center-West Lakes
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Email: cancerresearch@mercydesmoines.org

Methodist West Hospital
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ID
Boise
Saint Alphonsus Cancer Care Center-Boise
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Boise
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Email: eslinget@slhs.org

Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
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Email: stephanie.couch@stjoeshealth.org

Coeur D'Alene
Kootenai Health - Coeur d'Alene
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Emmett
Walter Knox Memorial Hospital
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Fruitland
Saint Luke's Cancer Institute - Fruitland
Contact: Site Public Contact
Email: eslinget@slhs.org

Meridian
Idaho Urologic Institute-Meridian
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Email: stephanie.couch@stjoeshealth.org

Saint Luke's Cancer Institute - Meridian
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Email: eslinget@slhs.org

Nampa
Saint Alphonsus Medical Center-Nampa
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Email: mccinfo@mtcancer.org

Saint Luke's Cancer Institute - Nampa
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Email: eslinget@slhs.org

Post Falls
Kootenai Clinic Cancer Services - Post Falls
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Email: mccinfo@mtcancer.org

Sandpoint
Kootenai Cancer Clinic
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Email: mccinfo@mtcancer.org

Twin Falls
Saint Luke's Cancer Institute - Twin Falls
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Email: eslinget@slhs.org

IL
Chicago
Northwestern University
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Email: cancer@northwestern.edu

Lake Forest
Northwestern Medicine Lake Forest Hospital
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Email: cancertrials@northwestern.edu

IN
Indianapolis
Franciscan Health Indianapolis
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Indiana University/Melvin and Bren Simon Cancer Center
Contact: Anita Turk
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Mooresville
Franciscan Health Mooresville
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Richmond
Reid Health
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Email: clinical.trials@daytonncorp.org

Terre Haute
Union Hospital
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KS
Fairway
University of Kansas Clinical Research Center
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Hays
HaysMed University of Kansas Health System
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Kansas City
University of Kansas Cancer Center
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Email: KUCC_Navigation@kumc.edu

University of Kansas Cancer Center-West
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Lawrence
Lawrence Memorial Hospital
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Email: Stephanie.Norris@LMH.ORG

Olathe
Olathe Health Cancer Center
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Email: Jeni.wakefield@olathehealth.org

Overland Park
University of Kansas Cancer Center-Overland Park
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Pittsburg
Ascension Via Christi - Pittsburg
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Email: jennifer.jameson@ascension.org

Salina
Salina Regional Health Center
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Email: mleepers@srhc.com

Topeka
University of Kansas Health System Saint Francis Campus
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Westwood
University of Kansas Hospital-Westwood Cancer Center
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KY
Bardstown
Flaget Memorial Hospital
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Email: ResearchInstituteInquiries@CommonSpirit.org

Corbin
Commonwealth Cancer Center-Corbin
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Email: ResearchInstituteInquiries@CommonSpirit.org

Lexington
Saint Joseph Hospital East
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Saint Joseph Radiation Oncology Resource Center
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London
Saint Joseph London
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Louisville
Jewish Hospital
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Saints Mary and Elizabeth Hospital
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UofL Health Medical Center Northeast
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Shepherdsville
Jewish Hospital Medical Center South
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MA
Springfield
Mercy Medical Center
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Worcester
UMass Memorial Medical Center - University Campus
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Email: cancer.research@umassmed.edu

ME
Brewer
Lafayette Family Cancer Center-EMMC
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MI
Ann Arbor
Saint Joseph Mercy Hospital
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Email: MCRCwebsitecontactform@stjoeshealth.org

Battle Creek
Bronson Battle Creek
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Email: crcwm-regulatory@crcwm.org

Bay City
McLaren Cancer Institute-Bay City
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Email: ctoadmin@karmanos.org

Brighton
Saint Joseph Mercy Brighton
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Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Brighton
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Email: MCRCwebsitecontactform@stjoeshealth.org

Canton
Saint Joseph Mercy Canton
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Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Canton
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Email: MCRCwebsitecontactform@stjoeshealth.org

Caro
Caro Cancer Center
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Email: lori.srebinski@ascension.org

Chelsea
Saint Joseph Mercy Chelsea
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Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
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Email: MCRCwebsitecontactform@stjoeshealth.org

Clarkston
Hematology Oncology Consultants-Clarkston
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Email: MCRCwebsitecontactform@stjoeshealth.org

McLaren Cancer Institute-Clarkston
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Email: ctoadmin@karmanos.org

Newland Medical Associates-Clarkston
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Email: MCRCwebsitecontactform@stjoeshealth.org

Detroit
Ascension Saint John Hospital
Contact: Site Public Contact
Email: karen.forman@ascension.org

Wayne State University/Karmanos Cancer Institute
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Email: ctoadmin@karmanos.org

East China
Great Lakes Cancer Management Specialists-Doctors Park
Contact: Site Public Contact
Email: karen.forman@ascension.org

Farmington Hills
Weisberg Cancer Treatment Center
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Email: ctoadmin@karmanos.org

Flint
Genesee Cancer and Blood Disease Treatment Center
Contact: Site Public Contact
Email: wstrong@ghci.org

Genesee Hematology Oncology PC
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Email: wstrong@ghci.org

Genesys Hurley Cancer Institute
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Email: wstrong@ghci.org

Hurley Medical Center
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Email: wstrong@ghci.org

McLaren Cancer Institute-Flint
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Singh and Arora Hematology Oncology PC
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Grand Rapids
Helen DeVos Children's Hospital at Spectrum Health
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Mercy Health Saint Mary's
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Spectrum Health at Butterworth Campus
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Grosse Pointe Woods
Academic Hematology Oncology Specialists
Contact: Site Public Contact
Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Grosse Pointe Woods
Contact: Site Public Contact
Email: karen.forman@ascension.org

Kalamazoo
Borgess Medical Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Bronson Methodist Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

West Michigan Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Lansing
Karmanos Cancer Institute at McLaren Greater Lansing
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Mid-Michigan Physicians-Lansing
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Sparrow Hospital
Contact: Site Public Contact

Lapeer
McLaren Cancer Institute-Lapeer Region
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Livonia
Hope Cancer Clinic
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Trinity Health Saint Mary Mercy Livonia Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Macomb Township
Contact: Site Public Contact
Email: karen.forman@ascension.org

Marlette
Saint Mary's Oncology/Hematology Associates of Marlette
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Mount Clemens
McLaren Cancer Institute-Macomb
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Mount Pleasant
McLaren Cancer Institute-Central Michigan
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Muskegon
Mercy Health Mercy Campus
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Niles
Lakeland Hospital Niles
Contact: Site Public Contact

Norton Shores
Cancer and Hematology Centers of Western Michigan - Norton Shores
Contact: Site Public Contact
Email: connie.szczepanek@crcwm.org

Petoskey
McLaren Cancer Institute-Northern Michigan
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Pontiac
21st Century Oncology-Pontiac
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Hope Cancer Center
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Email: MCRCwebsitecontactform@stjoeshealth.org

Newland Medical Associates-Pontiac
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Email: MCRCwebsitecontactform@stjoeshealth.org

Saint Joseph Mercy Oakland
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Email: MCRCwebsitecontactform@stjoeshealth.org

Port Huron
McLaren-Port Huron
Contact: Site Public Contact
Email: ctoadmin@karmanos.org

Reed City
Spectrum Health Reed City Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Rochester Hills
Great Lakes Cancer Management Specialists-Rochester Hills
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org

Saginaw
Ascension Saint Mary's Hospital
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Oncology Hematology Associates of Saginaw Valley PC
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Saint Joseph
Lakeland Medical Center Saint Joseph
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Marie Yeager Cancer Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Contact: Site Public Contact
Email: karen.forman@ascension.org

Tawas City
Ascension Saint Joseph Hospital
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Traverse City
Munson Medical Center
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Warren
Advanced Breast Care Center PLLC
Contact: Site Public Contact
Email: karen.forman@ascension.org

Great Lakes Cancer Management Specialists-Macomb Professional Building
Contact: Site Public Contact
Email: karen.forman@ascension.org

Macomb Hematology Oncology PC
Contact: Site Public Contact
Email: karen.forman@ascension.org

Michigan Breast Specialists-Warren
Contact: Site Public Contact
Email: karen.forman@ascension.org

Saint John Macomb-Oakland Hospital
Contact: Site Public Contact
Email: karen.forman@ascension.org

West Branch
Saint Mary's Oncology/Hematology Associates of West Branch
Contact: Site Public Contact
Email: lori.srebinski@ascension.org

Wyoming
Metro Health Hospital
Contact: Site Public Contact
Email: crcwm-regulatory@crcwm.org

Ypsilanti
Huron Gastroenterology PC
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org

MN
Burnsville
Fairview Ridges Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minnesota Oncology - Burnsville
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Cambridge
Cambridge Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Coon Rapids
Mercy Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Edina
Fairview Southdale Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Fridley
Unity Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maple Grove
Fairview Clinics and Surgery Center Maple Grove
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Maplewood
Minnesota Oncology Hematology PA-Maplewood
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Minneapolis
Abbott-Northwestern Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Health Partners Inc
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Hennepin County Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Monticello
Monticello Cancer Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

New Ulm
New Ulm Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Princeton
Fairview Northland Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Robbinsdale
North Memorial Medical Health Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Saint Paul
Regions Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

United Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Shakopee
Saint Francis Regional Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Stillwater
Lakeview Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Waconia
Ridgeview Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Willmar
Rice Memorial Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Woodbury
Minnesota Oncology Hematology PA-Woodbury
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

Wyoming
Fairview Lakes Medical Center
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

MO
Kansas City
Truman Medical Centers
Contact: Site Public Contact

University of Kansas Cancer Center - North
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

Lee's Summit
University of Kansas Cancer Center - Lee's Summit
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

North Kansas City
University of Kansas Cancer Center at North Kansas City Hospital
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu

MT
Anaconda
Community Hospital of Anaconda
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Billings
Billings Clinic Cancer Center
Contact: Site Public Contact
Email: research@billingsclinic.org

Bozeman
Bozeman Deaconess Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls
Benefis Healthcare- Sletten Cancer Institute
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Great Falls Clinic
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Kalispell
Kalispell Regional Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Missoula
Community Medical Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Saint Patrick Hospital - Community Hospital
Contact: Site Public Contact
Email: amy.hanneman@providence.org

NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Contact: Site Public Contact
Email: cancerclinicaltrials@med.unc.edu

Greenville
East Carolina University
Contact: Site Public Contact
Email: eubankss@ecu.edu

Hillsborough
University of North Carolina-Hillsborough Campus
Contact: Site Public Contact
Email: cancerclinicaltrials@med.unc.edu

NE
Grand Island
CHI Health Saint Francis
Contact: Site Public Contact

Kearney
CHI Health Good Samaritan
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Lincoln
Saint Elizabeth Regional Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Omaha
Alegent Health Bergan Mercy Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Immanuel Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Alegent Health Lakeside Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Creighton University Medical Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Nebraska Methodist Hospital
Contact: Site Public Contact

Papillion
Midlands Community Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

NH
Lebanon
Dartmouth Hitchcock Medical Center
Contact: Site Public Contact
Email: cancer.research.nurse@dartmouth.edu

NJ
Teaneck
Holy Name Hospital
Contact: Site Public Contact

NV
Carson City
Carson Tahoe Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Henderson
Cancer and Blood Specialists-Henderson
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Henderson
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Horizon Ridge
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Southeast Henderson
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Henderson
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Cancer Center-Henderson
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Green Valley
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Pebble
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Seven Hills
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Green Valley
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Contact: Site Public Contact
Email: research@sncrf.org

Ann M Wierman MD LTD
Contact: Site Public Contact
Email: research@sncrf.org

Cancer and Blood Specialists-Shadow
Contact: Site Public Contact
Email: research@sncrf.org

Cancer and Blood Specialists-Tenaya
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Northwest
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada - Town Center
Contact: Site Public Contact
Email: research@sncrf.org

Comprehensive Cancer Centers of Nevada-Summerlin
Contact: Site Public Contact
Email: research@sncrf.org

Desert West Surgery
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Fort Apache
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Las Vegas
Contact: Site Public Contact
Email: research@sncrf.org

GenesisCare USA - Vegas Tenaya
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-San Martin
Contact: Site Public Contact
Email: research@sncrf.org

HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Contact: Site Public Contact
Email: research@sncrf.org

Hope Cancer Care of Nevada
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Cancer Center-Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Prostate Cancer Center
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Cathedral Rock
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Pecos
Contact: Site Public Contact
Email: research@sncrf.org

Las Vegas Urology - Smoke Ranch
Contact: Site Public Contact
Email: research@smcrf.org

Las Vegas Urology - Sunset
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Charleston
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at Fort Apache
Contact: Site Public Contact
Email: research@sncrf.org

OptumCare Cancer Care at MountainView
Contact: Site Public Contact
Email: research@sncrf.org

Radiation Oncology Centers of Nevada Central
Contact: Site Public Contact
Email: research@sncrf.org

Radiation Oncology Centers of Nevada Southeast
Contact: Site Public Contact
Email: research@sncrf.org

Summerlin Hospital Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Sunrise Hospital and Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

University Cancer Center
Contact: Site Public Contact
Email: research@sncrf.org

University Medical Center of Southern Nevada
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Central
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Northwest
Contact: Site Public Contact
Email: research@sncrf.org

Urology Specialists of Nevada - Southwest
Contact: Site Public Contact
Email: research@sncrf.org

Pahrump
Hope Cancer Care of Nevada-Pahrump
Contact: Site Public Contact
Email: research@sncrf.org

Reno
Radiation Oncology Associates
Contact: Site Public Contact
Email: research@sncrf.org

Renown Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

Saint Mary's Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org

NY
Buffalo
Roswell Park Cancer Institute
Contact: Site Public Contact
Email: askroswell@roswellpark.org

Rochester
University of Rochester
Contact: Site Public Contact

OH
Beavercreek
Indu and Raj Soin Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Boardman
Saint Elizabeth Boardman Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Centerville
Dayton Physicians LLC-Miami Valley South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital South
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Cincinnati
Bethesda North Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Good Samaritan Hospital - Cincinnati
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Oncology Hematology Care Inc-Kenwood
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

TriHealth Cancer Institute-Anderson
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

TriHealth Cancer Institute-Westside
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Cleveland
Cleveland Clinic Cancer Center/Fairview Hospital
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

Cleveland Clinic Foundation
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

MetroHealth Medical Center
Contact: Site Public Contact
Email: dstrater@metrohealth.org

Dayton
Dayton Physician LLC-Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Findlay
Armes Family Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Blanchard Valley Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Orion Cancer Care
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Franklin
Atrium Medical Center-Middletown Regional Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Dayton Physicians LLC-Atrium
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Greenville
Dayton Physicians LLC-Wayne
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Wayne Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering
First Dayton Cancer Care
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Greater Dayton Cancer Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Kettering Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Mansfield
Cleveland Clinic Cancer Center Mansfield
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

Mayfield Heights
Hillcrest Hospital Cancer Center
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

Sandusky
North Coast Cancer Care
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

Strongsville
Cleveland Clinic Cancer Center Strongsville
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

Troy
Dayton Physicians LLC-Upper Valley
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Upper Valley Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Warren
Saint Joseph Warren Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Warrensville Heights
South Pointe Hospital
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

Wooster
Cleveland Clinic Wooster Family Health and Surgery Center
Contact: Site Public Contact
Email: TaussigResearch@ccf.org

Youngstown
Saint Elizabeth Youngstown Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

OK
Lawton
Cancer Centers of Southwest Oklahoma Research
Contact: Site Public Contact

Oklahoma City
University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu

OR
Baker City
Saint Alphonsus Medical Center-Baker City
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Bend
Saint Charles Health System
Contact: Site Public Contact
Email: nosall@stcharleshealthcare.org

Clackamas
Clackamas Radiation Oncology Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Cancer Institute Clackamas Clinic
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Coos Bay
Bay Area Hospital
Contact: Site Public Contact
Email: cherie.cox@bayareahospital.org

Newberg
Providence Newberg Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Ontario
Saint Alphonsus Medical Center-Ontario
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

Portland
Providence Portland Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org

Redmond
Saint Charles Health System-Redmond
Contact: Site Public Contact

PA
Allentown
Lehigh Valley Hospital-Cedar Crest
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Bethlehem
Lehigh Valley Hospital - Muhlenberg
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

East Stroudsburg
Pocono Medical Center
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Hazleton
Lehigh Valley Hospital-Hazleton
Contact: Site Public Contact
Email: Morgan_M.Horton@lvhn.org

Philadelphia
Fox Chase Cancer Center
Contact: Site Public Contact

Temple University Hospital
Contact: Site Public Contact

University of Pennsylvania/Abramson Cancer Center
Contact: Site Public Contact

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Contact: Site Public Contact

SC
Boiling Springs
Prisma Health Cancer Institute - Spartanburg
Contact: Site Public Contact

Easley
Prisma Health Cancer Institute - Easley
Contact: Site Public Contact
Email: Kim.Williams3@prismahealth.org

Greenville
Prisma Health Cancer Institute - Butternut
Contact: Site Public Contact

Prisma Health Cancer Institute - Eastside
Contact: Site Public Contact

Prisma Health Cancer Institute - Faris
Contact: Site Public Contact

Greer
Prisma Health Cancer Institute - Greer
Contact: Site Public Contact

Seneca
Prisma Health Cancer Institute - Seneca
Contact: Site Public Contact

SD
Sioux Falls
Avera Cancer Institute
Contact: Site Public Contact
Email: OncRegulatory@avera.org

TN
Bristol
Bristol Regional Medical Center
Contact: Site Public Contact
Email: justin.reynolds@wellmont.org

Franklin
Vanderbilt-Ingram Cancer Center Cool Springs
Contact: Site Public Contact

Vanderbilt-Ingram Cancer Center at Franklin
Contact: Site Public Contact

Kingsport
Ballad Health Cancer Care โ€“ Kingsport
Contact: Site Public Contact
Email: Justin.reynolds@balladhealth.org

Wellmont Holston Valley Hospital and Medical Center
Contact: Site Public Contact
Email: justin.reynolds@wellmont.org

Nashville
Vanderbilt Breast Center at One Hundred Oaks
Contact: Site Public Contact

Vanderbilt University/Ingram Cancer Center
Contact: Site Public Contact

TX
Bryan
Saint Joseph Regional Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org

Dallas
Parkland Memorial Hospital
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

UT Southwestern/Simmons Cancer Center-Dallas
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

Fort Worth
UT Southwestern/Simmons Cancer Center-Fort Worth
Contact: Site Public Contact
Email: canceranswerline@UTSouthwestern.edu

Richardson
UT Southwestern Clinical Center at Richardson/Plano
Contact: Site Public Contact
Email: Suzanne.cole@utsouthwestern.edu

VA
Bristol
Wellmont Medical Associates-Bristol
Contact: Site Public Contact
Email: justin.reynolds@wellmont.org

Martinsville
Sovah Health Martinsville
Contact: Site Public Contact
Email: sharon.hubbard@lpnt.net

Norton
Southwest VA Regional Cancer Center
Contact: Site Public Contact
Email: justin.reynolds@wellmont.org

WI
Madison
University of Wisconsin Carbone Cancer Center
Contact: Site Public Contact

Menomonee Falls
Froedtert Menomonee Falls Hospital
Contact: Site Public Contact

Milwaukee
Medical College of Wisconsin
Contact: Site Public Contact

New Richmond
Cancer Center of Western Wisconsin
Contact: Site Public Contact
Email: mmcorc@healthpartners.com

West Bend
Froedtert West Bend Hospital/Kraemer Cancer Center
Contact: Site Public Contact

WY
Cody
Billings Clinic-Cody
Contact: Site Public Contact
Email: research@billingsclinic.org

Sheridan
Welch Cancer Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org

PRIMARY OBJECTIVE:
I. To determine the objective response rate of pevonedistat as a single agent and in combination with carboplatin and paclitaxel in patients with unresectable intrahepatic cholangiocarcinoma.

SECONDARY OBJECTIVES:
I. To evaluate the safety profile of pevonedistat alone and in combination with carboplatin and paclitaxel in patients with intrahepatic cholangiocarcinoma.
II. To determine the clinical benefit rate of patients with advanced intrahepatic cholangiocarcinoma (ICC) treated with pevonedistat monotherapy and in combination with carboplatin and paclitaxel.
III. To determine progression-free survival of patients treated with pevonedistat monotherapy and in combination with carboplatin and paclitaxel.
IV. To determine overall survival of patients treated with pevonedistat monotherapy and in combination with carboplatin and paclitaxel.

EXPLORATORY OBJECTIVES:
I. To determine whether overexpression of NEDD8, NAE1, and UBC12 predict response to treatment.
II. To identify the mutation profile of those cholangiocarcinomas with overexpression of the neddylation pathway.
III. To bank specimens for further future investigations.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive pevonedistat intravenously (IV) over 60 minutes on days 1, 3, and 5. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive pevonedistat IV over 1 hour on days 1, 3, and 5, paclitaxel IV over 3 hours on day 1, and carboplatin IV over 15-60 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Starting cycle 5, patients may receive pevonedistat monotherapy at the discretion of treating physician.

After completion of study treatment, patients are followed up at 30 days after last dose of study treatment, then every 3 months for the first year and every 6 months for years 2-3.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


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