Pancreas Cancer
EA2192 / APOLLO
APOLLO: A Randomized Phase II Double-Blind Study of Olaparib versus Placebo Following Curative Intent Therapy in Patients with Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
STATUS: Active
This phase II trial investigates how well the addition of olaparib following completion of surgery and chemotherapy works in treating patients with pancreatic cancer that has been surgically removed (resected) and has a pathogenic mutation in BRCA1, BRCA2, or PALB2. Olaparib is an inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes damaged. Blocking PARP may help keep tumor cells from repairing their damaged DNA, causing them to die. PARP inhibitors are a type of targeted therapy.
- STEP 0 (PRE-REGISTRATION) INCLUSION CRITERIA
- Patient must be >= 18 years of age on day of consent
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Patient must have a diagnosis of pancreatic cancer and have successfully undergone a curative intent surgical resection and must have no evidence of recurrent disease as determined by the investigator * NOTE: This includes patients with adenocarcinoma, acinar carcinoma, squamous cell carcinoma adenosquamous and variants thereof. Patients with neuroendocrine tumors are excluded from enrolling
- Patient must (1) be planning to receive, (2) be receiving or (3) have received at least three combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 month course)
- Patient must be no more than 12 weeks from their most recent treatment (this may be chemotherapy, radiotherapy or surgery)
- Patient must have a known pathogenic or likely pathogenic germline or somatic mutation in BRCA1, BRCA2, or PALB2, as determined by a Clinical Laboratory Improvement Amendments (CLIA) certified or equivalently-accredited laboratory. Mutations must be considered pathogenic or likely pathogenic by a reference database such as ClinVar or OncoKb.org
- STEP 1 (RANDOMIZATION) INCLUSION CRITERIA
- Patient must have met the eligibility criteria outlined above
- Patient must have undergone at least 3 combined months (i.e., 12 weeks) of perioperative (neoadjuvant, adjuvant or a combination of both) systemic, multi-agent chemotherapy. Patients may have had up to 6 months of perioperative systemic therapy as deemed appropriate by their primary treating medical team (patients can have received radiation or chemoradiation in addition to this 6 months course)
- Central expert reviewer must have determined the patient eligible for randomization after review of local genetic testing reports
- If mutation in BRCA1, BRCA2 or PALB2 was identified in tumor tissue and the patient has not previously undergone germline testing, the patient must agree to undergo germline testing
- Patient must have no evidence of recurrent or metastatic pancreatic cancer at the time of randomization as documented by baseline scans obtained =< 4 weeks prior to Step 1 randomization
- Patient must not have previously had evidence of progressive pancreatic cancer while receiving platinum-based therapy
- Patient must be >= 21 days (three weeks) from their last treatment (including chemotherapy radiotherapy or surgery) but =< 84 days (twelve weeks) from their last treatment at the time of Step 1 randomization. Patients who have received neoadjuvant and/or adjuvant radiotherapy are eligible
- Patient must have recovered from any adverse events due to prior anti-cancer therapy (i.e., have no residual toxicities > grade 1 with the exception of alopecia and/or neuropathy)
- Patient must not be receiving any other investigational agents at the time of Step 1 randomization and while on protocol treatment
- Patient must not have any history of allergic reactions attributed to compounds of similar chemical or biological composition to olaparib
- Patient must not have any personal history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML.
- Patient must not have any uncontrolled gastrointestinal disorder that would, in the opinion of the investigator, interfere with the ingestion or absorption of olaparib
- Patient must not be pregnant or breast-feeding due the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 1 randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, 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)
- Patients 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 for 6 months after the last dose of protocol treatment for female patients and for 3 months after the last dose of protocol treatment for male patients. Patients must also not donate sperm while on protocol treatment and for 3 months after the last dose of protocol treatment. Patients must also not breast-feed while on protocol treatment and for 1 month after the last dose of protocol treatment
- Leukocytes >= 3,000/mcL (obtained =< 28 days prior to Step 1 randomization)
- Absolute neutrophil count >= 1,500/mcL (obtained =< 28 days prior to Step 1 randomization)
- Platelets >= 100,000/mcL (obtained =< 28 days prior to Step 1 randomization)
- Hemoglobin >= 9.0 g/dL with no blood transfusion in the past 28 days (obtained =< 28 days prior to Step 1 randomization)
- Total bilirubin =< 1.5 institutional upper limit of normal (ULN) except in patients with Gilbert’s syndrome. Patients with Gilbert’s syndrome may enroll if direct bilirubin =< 2.5 x ULN of the direct bilirubin (obtained =< 28 days prior to Step 1 randomization)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.5 institutional ULN (obtained =< 28 days prior to Step 1 randomization)
- Creatinine =< 1.5 institutional ULN OR calculated Cockcroft Gault creatinine clearance > 50 mL/min/1.73 m^2 (obtained =< 28 days prior to Step 1 randomization)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
- 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
- Patient must not have resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (e.g. unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, corrected QT [QTc] prolongation > 500 ms, electrolyte disturbances, etc.) or have congenital long QT syndrome
- Concomitant use of known potent CYP3A4/5 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir is prohibited
- Patients who are being actively treated for an ongoing concurrent malignancy are ineligible, with the exception of those receiving adjuvant hormone therapies and those receiving topical therapies for skin cancers
- Patient must not have, in the opinion of the investigator, any other concurrent medical condition that would prevent the patient from complying with the study procedures
- Patient must not be considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, extensive interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan or any psychiatric disorder that prohibits obtaining informed consent
- Patient must have the ability to understand and the willingness to sign a written informed consent document, or have legally authorized representative provide authorization to participate
- Patient must not have had major surgery within 2 weeks prior to Step 1 randomization and patients must have recovered from any effects of any major surgery
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Saint Anthony Regional Hospital
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Alegent Health Mercy Hospital
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Greater Regional Medical Center
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Broadlawns Medical Center
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McFarland Clinic - Trinity Cancer Center
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McFarland Clinic - Jefferson
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McFarland Clinic - Marshalltown
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Mercy Medical Center-West Lakes
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Boise
Saint Luke's Cancer Institute - Boise
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Saint Luke's Cancer Institute - Fruitland
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Saint Luke's Cancer Institute - Meridian
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Saint Luke's Cancer Institute - Nampa
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Saint Luke's Cancer Institute - Twin Falls
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Alton
OSF Saint Anthony's Health Center
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Rush - Copley Medical Center
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Illinois CancerCare-Bloomington
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Illinois CancerCare-Canton
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Memorial Hospital of Carbondale
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SIH Cancer Institute
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Illinois CancerCare-Carthage
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Centralia Oncology Clinic
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University of Chicago Comprehensive Cancer Center
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Carle at The Riverfront
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Cancer Care Specialists of Illinois - Decatur
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Illinois CancerCare-Dixon
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Carle Physician Group-Effingham
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Elmhurst Memorial Hospital
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Edward Hospital/Cancer Center
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Hickman Cancer Center
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Henry Ford Saint John Hospital - Macomb Medical
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Toledo Clinic Cancer Centers-Monroe
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Henry Ford Health Providence Novi Hospital
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Michigan Healthcare Professionals Pontiac
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Corewell Health William Beaumont University Hospital
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Henry Ford Health Providence Southfield Hospital
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Bhadresh Nayak MD PC-Sterling Heights
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MyMichigan Medical Center Tawas
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Corewell Health Beaumont Troy Hospital
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Henry Ford Health Warren Hospital
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Saint Mary's Oncology/Hematology Associates of West Branch
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Huron Gastroenterology PC
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MN
Bemidji
Sanford Joe Lueken Cancer Center
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Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Duluth
Saint Luke's Hospital of Duluth
Contact: Site Public Contact
Email: kdean@slhduluth.com
Minneapolis
Abbott-Northwestern Hospital
Contact: Site Public Contact
Email: mmcorc@healthpartners.com
Rochester
Mayo Clinic in Rochester
Contact: Site Public Contact
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
MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Contact: Site Public Contact
Bolivar
Central Care Cancer Center - Bolivar
Contact: Site Public Contact
Email: aroland@kccop.org
Cape Girardeau
Saint Francis Medical Center
Contact: Site Public Contact
Email: sfmc@sfmc.net
Southeast Cancer Center
Contact: Site Public Contact
Farmington
Parkland Health Center - Farmington
Contact: Site Public Contact
Jefferson City
MU Health Care Goldschmidt Cancer Center
Contact: Site Public Contact
Email: amy.franken@health.missouri.edu
Joplin
Freeman Health System
Contact: Site Public Contact
Email: LJCrockett@freemanhealth.com
Mercy Hospital Joplin
Contact: Site Public Contact
Email: esmeralda.carrillo@mercy.net
Kansas City
Saint Luke's Hospital of Kansas City
Contact: Site Public Contact
Email: aroland@kccop.org
University Health Truman Medical Center
Contact: Site Public Contact
University of Kansas Cancer Center - North
Contact: Site Public Contact
Email: KUCC_Navigation@kumc.edu
Lee's Summit
Saint Luke's East - Lee's Summit
Contact: Site Public Contact
Email: aroland@kccop.org
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
Rolla
Delbert Day Cancer Institute at PCRMC
Contact: Site Public Contact
Email: research@phelpshealth.org
Mercy Clinic-Rolla-Cancer and Hematology
Contact: Site Public Contact
Saint Joseph
Heartland Regional Medical Center
Contact: Site Public Contact
Email: Trisha.England2@mymlc.com
Saint Louis
Mercy Hospital Saint Louis
Contact: Site Public Contact
Mercy Hospital South
Contact: Site Public Contact
Email: Danielle.Werle@mercy.net
Missouri Baptist Medical Center
Contact: Site Public Contact
Saint Louis Cancer and Breast Institute-South City
Contact: Site Public Contact
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
Contact: Site Public Contact
Springfield
CoxHealth South Hospital
Contact: Site Public Contact
Mercy Hospital Springfield
Contact: Site Public Contact
Sullivan
Missouri Baptist Sullivan Hospital
Contact: Site Public Contact
Sunset Hills
BJC Outpatient Center at Sunset Hills
Contact: Site Public Contact
Washington
Mercy Hospital Washington
Contact: Site Public Contact
MS
Columbus
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org
Grenada
Baptist Cancer Center-Grenada
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org
New Albany
Baptist Memorial Hospital and Cancer Center-Union County
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org
Oxford
Baptist Memorial Hospital and Cancer Center-Oxford
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org
Southhaven
Baptist Memorial Hospital and Cancer Center-Desoto
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org
MT
Missoula
Saint Patrick Hospital - Community Hospital
Contact: Site Public Contact
Email: amy.hanneman@providence.org
NC
Clinton
Southeastern Medical Oncology Center-Clinton
Contact: Site Public Contact
Email: jfields@cancersmoc.com
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Contact: Site Public Contact
Email: jfields@cancersmoc.com
Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Contact: Site Public Contact
Email: jfields@cancersmoc.com
ND
Bismarck
Sanford Bismarck Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Fargo
Sanford Broadway Medical Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
Sanford Roger Maris Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
NE
Grand Island
Nebraska Cancer Specialists/Oncology Hematology West PC
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 Cancer Specialists/Oncology Hematology West PC - MECC
Contact: Site Public Contact
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/Dartmouth Cancer Center
Contact: Site Public Contact
Email: cancer.research.nurse@dartmouth.edu
NJ
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Contact: Site Public Contact
Camden
Cooper Hospital University Medical Center
Contact: Site Public Contact
Middletown
Memorial Sloan Kettering Monmouth
Contact: Site Public Contact
Montvale
Memorial Sloan Kettering Bergen
Contact: Site Public Contact
Teaneck
Holy Name Hospital
Contact: Site Public Contact
Voorhees
MD Anderson Cancer Center at Cooper-Voorhees
Contact: Site Public Contact
NM
Albuquerque
University of New Mexico Cancer Center
Contact: Site Public Contact
Email: HSC-ClinicalTrialInfo@salud.unm.edu
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
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
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
Commack
Memorial Sloan Kettering Commack
Contact: Site Public Contact
Greenlawn
Northwell Health Cancer Institute at Huntington
Contact: Site Public Contact
Lake Success
Northwell Health/Center for Advanced Medicine
Contact: Site Public Contact
Mineola
NYU Langone Hospital - Long Island
Contact: Site Public Contact
Email: cancertrials@nyulangone.org
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Contact: Site Public Contact
Email: CancerTrials@nyulangone.org
Memorial Sloan Kettering Cancer Center
Contact: Site Public Contact
Rochester
Rochester General Hospital
Contact: Site Public Contact
Email: tia.derosa@rochestergeneral.org
Unity Park Ridge Campus
Contact: Site Public Contact
Email: ctsucontact@westat.com
Uniondale
Memorial Sloan Kettering Nassau
Contact: Site Public Contact
West Harrison
Memorial Sloan Kettering Westchester
Contact: Site Public Contact
OH
Centerville
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
TriHealth Cancer Institute-Anderson
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
TriHealth Cancer Institute-Westside
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Dayton
Dayton Physician LLC - Englewood
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
Premier Blood and Cancer Center
Contact: Site Public Contact
Franklin
Atrium Medical Center-Middletown Regional Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Greenville
Miami Valley Cancer Care and Infusion
Contact: Site Public Contact
Kettering
Kettering Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Toledo
Mercy Health - Saint Anne Hospital
Contact: Site Public Contact
Email: Jeffh@columbusccop.org
Toledo Clinic Cancer Centers-Toledo
Contact: Site Public Contact
Troy
Upper Valley Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
OK
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact
University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu
OR
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
Oregon City
Providence Willamette Falls Medical Center
Contact: Site Public Contact
Email: CanRsrchStudies@providence.org
Portland
Oregon Health and Science University
Contact: Site Public Contact
Email: trials@ohsu.edu
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
Bryn Mawr
Bryn Mawr Hospital
Contact: Site Public Contact
Email: turzoe@mlhs.org
Collegeville
Main Line Health Center-Collegeville
Contact: Site Public Contact
Email: turzoe@mlhs.org
Exton
Main Line Health Center-Exton
Contact: Site Public Contact
Email: turzoe@mlhs.org
Media
Riddle Memorial Hospital
Contact: Site Public Contact
Email: turzoe@mlhs.org
Paoli
Paoli Memorial Hospital
Contact: Site Public Contact
Email: turzoe@mlhs.org
Philadelphia
Fox Chase Cancer Center
Contact: Site Public Contact
University of Pennsylvania/Abramson Cancer Center
Contact: Site Public Contact
Email: PennCancerTrials@careboxhealth.com
Wynnewood
Lankenau Medical Center
Contact: Site Public Contact
Email: turzoe@mlhs.org
SD
Aberdeen
Avera Cancer Institute-Aberdeen
Contact: Site Public Contact
Email: oncregulatory@avera.org
Sioux Falls
Avera Cancer Institute
Contact: Site Public Contact
Email: OncRegulatory@avera.org
Sanford Cancer Center Oncology Clinic
Contact: Site Public Contact
Email: OncologyClinicTrialsSF@sanfordhealth.org
Sanford USD Medical Center - Sioux Falls
Contact: Site Public Contact
Email: OncologyClinicalTrialsSF@SanfordHealth.org
TN
Collierville
Baptist Memorial Hospital and Cancer Center-Collierville
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org
Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Contact: Site Public Contact
Email: BCCclintrials@bmhcc.org
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 - RedBird
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
UT
Farmington
Farmington Health Center
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu
Salt Lake City
Huntsman Cancer Institute/University of Utah
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu
University of Utah Sugarhouse Health Center
Contact: Site Public Contact
Email: cancerinfo@hci.utah.edu
VT
Saint Johnsbury
Dartmouth Cancer Center - North
Contact: Site Public Contact
Email: cancer.research.nurse@hitchcock.org
WA
Aberdeen
Providence Regional Cancer System-Aberdeen
Contact: Site Public Contact
Email: deidre.dillon@providence.org
Auburn
MultiCare Auburn Medical Center
Contact: Site Public Contact
Email: research@multicare.org
Bellevue
Overlake Medical Center
Contact: Site Public Contact
Email: OHMCResearch@overlakehospital.org
Bellingham
PeaceHealth Saint Joseph Medical Center
Contact: Site Public Contact
Burien
Highline Medical Center-Main Campus
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Centralia
Providence Regional Cancer System-Centralia
Contact: Site Public Contact
Email: deidre.dillon@providence.org
Edmonds
Swedish Cancer Institute-Edmonds
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Enumclaw
Saint Elizabeth Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Everett
Providence Regional Cancer Partnership
Contact: Site Public Contact
Email: marilyn.birchman@providence.org
Federal Way
Saint Francis Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Gig Harbor
MultiCare Gig Harbor Medical Park
Contact: Site Public Contact
Email: research@multicare.org
Issaquah
Swedish Cancer Institute-Issaquah
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Kennewick
Kadlec Clinic Hematology and Oncology
Contact: Site Public Contact
Email: research@kadlecmed.org
Lacey
Providence Regional Cancer System-Lacey
Contact: Site Public Contact
Email: deidre.dillon@providence.org
Lakewood
Saint Clare Hospital
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Longview
PeaceHealth Saint John Medical Center
Contact: Site Public Contact
Email: kmakin-bond@peacehealth.org
Puyallup
MultiCare Good Samaritan Hospital
Contact: Site Public Contact
Email: research@multicare.org
Renton
Valley Medical Center
Contact: Site Public Contact
Email: research@valleymed.org
Seattle
Pacific Gynecology Specialists
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-Ballard Campus
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-Cherry Hill
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-First Hill
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Sedro-Woolley
PeaceHealth United General Medical Center
Contact: Site Public Contact
Email: rcrompton@peacehealth.org
Shelton
Providence Regional Cancer System-Shelton
Contact: Site Public Contact
Email: deidre.dillon@providence.org
Silverdale
Saint Michael Cancer Center
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
Spokane
MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
Contact: Site Public Contact
Email: research@multicare.org
MultiCare Deaconess Cancer and Blood Specialty Center - North
Contact: Site Public Contact
Email: research@multicare.org
Spokane Valley
MultiCare Deaconess Cancer and Blood Specialty Center - Valley
Contact: Site Public Contact
Email: research@multicare.org
Tacoma
Franciscan Research Center-Northwest Medical Plaza
Contact: Site Public Contact
Email: ResearchInstituteInquiries@CommonSpirit.org
MultiCare Tacoma General Hospital
Contact: Site Public Contact
Email: research@multicare.org
Vancouver
PeaceHealth Southwest Medical Center
Contact: Site Public Contact
Email: kmakin-bond@peacehealth.org
Walla Walla
Providence Saint Mary Regional Cancer Center
Contact: Site Public Contact
Email: Cheryl.Dodd@providence.org
Yakima
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Contact: Site Public Contact
Email: Memorial-ClinicalTrials@yvmh.org
Yelm
Providence Regional Cancer System-Yelm
Contact: Site Public Contact
Email: deidre.dillon@providence.org
WI
Appleton
ThedaCare Regional Cancer Center
Contact: Site Public Contact
Email: ResearchDept@thedacare.org
Eau Claire
Marshfield Medical Center-EC Cancer Center
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org
Saint Vincent Hospital Cancer Center at Saint Mary's
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org
Johnson Creek
University of Wisconsin Carbone Cancer Center - Johnson Creek
Contact: Site Public Contact
Email: clinicaltrials@cancer.wisc.edu
La Crosse
Gundersen Lutheran Medical Center
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org
Madison
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Contact: Site Public Contact
Email: clinicaltrials@cancer.wisc.edu
University of Wisconsin Carbone Cancer Center - University Hospital
Contact: Site Public Contact
Email: clinicaltrials@cancer.wisc.edu
Marshfield
Marshfield Medical Center-Marshfield
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Minocqua
Marshfield Medical Center - Minocqua
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Mukwonago
ProHealth D N Greenwald Center
Contact: Site Public Contact
Email: research.institute@phci.org
Oconomowoc
ProHealth Oconomowoc Memorial Hospital
Contact: Site Public Contact
Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org
Rice Lake
Marshfield Medical Center-Rice Lake
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Sheboygan
Saint Vincent Hospital Cancer Center at Sheboygan
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org
Stevens Point
Marshfield Medical Center-River Region at Stevens Point
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Contact: Site Public Contact
Email: ewd_research_admin@hshs.org
Waukesha
ProHealth Waukesha Memorial Hospital
Contact: Site Public Contact
UW Cancer Center at ProHealth Care
Contact: Site Public Contact
Email: Chanda.miller@phci.org
Weston
Marshfield Medical Center - Weston
Contact: Site Public Contact
Email: oncology.clinical.trials@marshfieldresearch.org
WV
Morgantown
West Virginia University Healthcare
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu
PRIMARY OBJECTIVE: I. To determine the relapse-free survival (RFS)-benefit from the addition of a maintenance olaparib following completion of chemotherapy in patients with resected pancreatic carcinoma and a pathogenic germline or somatic mutation in BRCA1, BRCA2 or PALB2. SECONDARY OBJECTIVES: I. To evaluate RFS in patients with olaparib after perioperative chemotherapy compared to those treated with perioperative therapy alone among patients who received prior platinum-based perioperative chemotherapy. II. To evaluate overall survival (OS) in patients treated with olaparib after adjuvant chemotherapy compared to those treated with adjuvant treatment alone. III. To analyze the efficacy of olaparib after chemotherapy in patients with a pathogenic germline BRCA or PALB2 mutation compared to those with a somatic mutation. IV. To analyze survival differences between patients who received neoadjuvant or perioperative chemotherapy compared to those who received adjuvant therapy alone. V. To analyze RFS and OS differences in those who received =< 3 months of perioperative platinum chemotherapy compared to those who received > 3 months of perioperative platinum chemotherapy. VI. To analyze RFS and OS differences in those who received any platinum-based perioperative chemotherapy compared to no-platinum based perioperative chemotherapy. EXPLORATORY OBJECTIVES: I. To analyze RFS and OS differences in patients who had R1 versus (vs) R0 resections, lymph node positivity at resection, and/or elevated or rising CA 19-9 or CEA at time of study enrollment in the post-operative setting. II. To analyze RFS and OS differences with those who had resectable disease at diagnosis compared to those who did not. III. To analyze RFS and OS differences in those with gBRCA1 mutations compared to those with gBRCA2 mutations and gPALB2 mutations. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive olaparib orally (PO) twice daily (BID) on days 1-28 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) scans or CT/magnetic resonance imaging (MRI) and collection of blood throughout the study. ARM II: Patients receive placebo PO BID on days 1-28 of each cycle. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT scans or CT/MRI and collection of blood throughout the study. After completion of study treatment, patients are followed up at 30 days, every 4 months for year 1, then every 6 months for years 2-10 after randomization.
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.