Various Cancer Types
EAY191-E4
Testing the Use of Nilotinib and Paclitaxel as a Treatment for Patients with Prior Taxane Treatment, A ComboMATCH Treatment Trial
STATUS: Closed to Accrual
This phase II ComboMATCH treatment trial evaluates nilotinib with paclitaxel for the treatment of patients with solid cancers that are growing, spreading, or getting worse (progressive) and that have previously been treated with taxane therapies. Nilotinib is in a class of medications called kinase inhibitors. It works by binding to and blocking the action of a protein called ABL, which signals tumor cells to multiply. This helps slow or stop the proliferation of tumor cells. Paclitaxel is a drug that blocks cell growth by stopping cell division and it may kill tumor cells. Giving nilotinib with paclitaxel may be effective at treating patients with progressive solid cancers that have previously been treated with taxane therapies.
- Patient must be enrolled on the ComboMATCH registration protocol (EAY191) at the time of registration to the EAY191-E4 study
- Patient must be >= 18 years of age
- Patient must not have any of the following mutations (as determined by the ComboMATCH registration protocol), which are known to confer sensitivity or resistance to nilotinib monotherapy: * KIT: W557R, V559D, V559A, L576P, and K642E * PDGFR-alpha: D842V
- Patient must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have archival tissue available from within 12 months prior to the date of registration on the ComboMATCH registration trial (EAY191) * NOTE: The current actionable mutation of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trials Support Unit (CTSU) website * NOTE: Novel/dynamic aMOI can be submitted for review per the process described in the ComboMATCH registration protocol
- Patient must be willing to provide blood samples for research purposes
- Patient must have had at least one prior line of therapy in the metastatic setting
- Patient must have previously undergone taxane therapy (in the metastatic setting) * Patients who previously responded to prior taxane therapy must have received their last dose of taxane therapy within 6 months prior to EAY191-E4 registration and have had no other intervening treatment prior to EAY191-E4 registration * Patients who did not respond to prior taxane therapy are eligible regardless of the time elapsed since the prior taxane therapy or any other intervening therapies
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Patient must not have had platinum-resistant epithelial serous ovarian cancer
- Patients must not have neuropathy >= grade 2 within 14 days of registration/randomization
- Patient must have documented QT interval with Fridericia’s correction (QTcF) of =< 450 msec within 8 days prior to EAY191-E4 registration. Patients with a QTcF interval of >= 450 msec at registration or patients with congenital long QT syndrome are not eligible
- Patient 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 * All patients of childbearing potential must have a blood test or urine study within 14 days prior to registration 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)
- Patient 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 at least 3 months after the last dose of study drug
- Patients must have progressive disease
- Absolute neutrophil count (ANC) >= 1,500/mcL
- Platelets >= 100,000/mcL
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (with the exception of those with Gilbert syndrome, who must have total bilirubin =< 3 x institutional ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 institutional upper limit of normal; < 5.0 x ULN in patients with liver metastases
- Creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 mg/dL
- Patient must have the ability to swallow medications
- Patient must have completed any prior therapy ≥ 4 weeks or ≥ 5 half-lives of the prior agent (whichever is shorter) prior to enrollment on protocol. Prior definitive radiation should have been completed ≥ 4 weeks prior to enrollment; prior palliative radiation should have been completed ≥ 2 weeks prior to enrollment. Patients must be ≥ 2 weeks since any investigational agent administered as part of a phase 0 study (where a sub-therapeutic dose of drug is administered) and should have recovered to grade 1 or baseline from any toxicities
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression for ≥ 1 month after treatment of the brain metastases
United States
AL
Birmingham
University of Alabama at Birmingham Cancer Center
Contact: Site Public Contact
Email: tmyrick@uab.edu
AZ
Kingman
Kingman Regional Medical Center
Contact: Site Public Contact
Email: research@sncrf.org
CA
Palo Alto
Stanford Cancer Institute Palo Alto
Contact: Site Public Contact
Email: ccto-office@stanford.edu
Whittier
Presbyterian Intercommunity Hospital
Contact: Site Public Contact
CO
Aurora
UCHealth University of Colorado Hospital
Contact: Site Public Contact
FL
Aventura
UM Sylvester Comprehensive Cancer Center at Aventura
Contact: Site Public Contact
Coral Gables
UM Sylvester Comprehensive Cancer Center at Coral Gables
Contact: Site Public Contact
Deerfield Beach
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
Contact: Site Public Contact
Miami
UM Sylvester Comprehensive Cancer Center at Kendall
Contact: Site Public Contact
University of Miami Miller School of Medicine-Sylvester Cancer Center
Contact: Site Public Contact
Plantation
UM Sylvester Comprehensive Cancer Center at Plantation
Contact: Site Public Contact
IA
Des Moines
Mission Cancer and Blood - Des Moines
Contact: Site Public Contact
ID
Boise
Saint Alphonsus Cancer Care Center-Boise
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Contact: Site Public Contact
Email: stephanie.couch@stjoeshealth.org
Coeur D'Alene
Kootenai Health - Coeur d'Alene
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Nampa
Saint Alphonsus Cancer Care Center-Nampa
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Post Falls
Kootenai Clinic Cancer Services - Post Falls
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Sandpoint
Kootenai Clinic Cancer Services - Sandpoint
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
IL
Barrington
Advocate Good Shepherd Hospital
Contact: Site Public Contact
Bloomington
Illinois CancerCare-Bloomington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Canton
Illinois CancerCare-Canton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Carthage
Illinois CancerCare-Carthage
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Centralia
Centralia Oncology Clinic
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Chicago
Advocate Illinois Masonic Medical Center
Contact: Site Public Contact
John H Stroger Jr Hospital of Cook County
Contact: Site Public Contact
Northwestern University
Contact: Site Public Contact
Email: cancer@northwestern.edu
Crystal Lake
AMG Crystal Lake - Oncology
Contact: Site Public Contact
Email: advocateresearch@advocate.com
Danville
Carle at The Riverfront
Contact: Site Public Contact
Email: Research@Carle.com
Decatur
Cancer Care Specialists of Illinois - Decatur
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Decatur Memorial Hospital
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Dixon
Illinois CancerCare-Dixon
Contact: Site Public Contact
Downers Grove
Advocate Good Samaritan Hospital
Contact: Site Public Contact
Email: Barbara.barhamand@advocatehealth.com
Effingham
Carle Physician Group-Effingham
Contact: Site Public Contact
Email: Research@carle.com
Crossroads Cancer Center
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Elgin
Advocate Sherman Hospital
Contact: Site Public Contact
Eureka
Illinois CancerCare-Eureka
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Galesburg
Illinois CancerCare-Galesburg
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Hazel Crest
Advocate South Suburban Hospital
Contact: Site Public Contact
Kewanee
Illinois CancerCare-Kewanee Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Libertyville
AMG Libertyville - Oncology
Contact: Site Public Contact
Email: advocateresearch@advocatehealth.com
Condell Memorial Hospital
Contact: Site Public Contact
Email: advocateresearch@advocatehealth.com
Macomb
Illinois CancerCare-Macomb
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Mattoon
Carle Physician Group-Mattoon/Charleston
Contact: Site Public Contact
Email: Research@carle.com
O'Fallon
Cancer Care Center of O'Fallon
Contact: Site Public Contact
Email: morganthaler.jodi@mhsil.com
Oak Lawn
Advocate Christ Medical Center
Contact: Site Public Contact
Ottawa
Illinois CancerCare-Ottawa Clinic
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Park Ridge
Advocate Lutheran General Hospital
Contact: Site Public Contact
Pekin
Illinois CancerCare-Pekin
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Peoria
Illinois CancerCare-Peoria
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Peru
Illinois CancerCare-Peru
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Princeton
Illinois CancerCare-Princeton
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
Springfield
Southern Illinois University School of Medicine
Contact: Site Public Contact
Springfield Clinic
Contact: Site Public Contact
Springfield Memorial Hospital
Contact: Site Public Contact
Email: pallante.beth@mhsil.com
Urbana
Carle Cancer Center
Contact: Site Public Contact
Email: Research@carle.com
Washington
Illinois CancerCare - Washington
Contact: Site Public Contact
Email: andersonj@illinoiscancercare.com
KY
Lexington
University of Kentucky/Markey Cancer Center
Contact: Site Public Contact
LA
New Orleans
Ochsner Medical Center Jefferson
Contact: Site Public Contact
Email: Elisemarie.curry@ochsner.org
MD
Bethesda
National Institutes of Health Clinical Center
Contact: Site Public Contact
ME
Brewer
Lafayette Family Cancer Center-EMMC
Contact: Site Public Contact
MI
Ann Arbor
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Brighton
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Trinity Health Medical Center - Brighton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Canton
Trinity Health IHA Medical Group Hematology Oncology - Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Trinity Health Medical Center - Canton
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Chelsea
Chelsea Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Flint
Genesee Cancer and Blood Disease Treatment Center
Contact: Site Public Contact
Email: wstrong@ghci.org
Genesee Hematology Oncology PC
Contact: Site Public Contact
Email: wstrong@ghci.org
Genesys Hurley Cancer Institute
Contact: Site Public Contact
Email: wstrong@ghci.org
Hurley Medical Center
Contact: Site Public Contact
Email: wstrong@ghci.org
Lansing
University of Michigan Health - Sparrow Lansing
Contact: Site Public Contact
Email: harsha.trivedi@umhsparrow.org
Livonia
Trinity Health Saint Mary Mercy Livonia Hospital
Contact: Site Public Contact
Email: MCRCwebsitecontactform@stjoeshealth.org
Macomb Township
Henry Ford Saint John Hospital - Macomb Medical
Contact: Site Public Contact
Email: kforman1@hfhs.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
Bemidji
Sanford Joe Lueken Cancer Center
Contact: Site Public Contact
Email: OncologyClinicalTrialsFargo@sanfordhealth.org
MO
Cape Girardeau
Saint Francis Medical Center
Contact: Site Public Contact
Email: sfmc@sfmc.net
Farmington
Parkland Health Center - Farmington
Contact: Site Public Contact
Saint Louis
Missouri Baptist Medical Center
Contact: Site Public Contact
Sainte Genevieve
Sainte Genevieve County Memorial Hospital
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
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 Health Deaconess Hospital
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Great Falls
Benefis Sletten Cancer Institute
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Kalispell
Logan Health Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
Missoula
Community Medical Center
Contact: Site Public Contact
Email: mccinfo@mtcancer.org
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
NV
Henderson
OptumCare Cancer Care at Seven Hills
Contact: Site Public Contact
Email: research@sncrf.org
Las Vegas
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
NY
Buffalo
Roswell Park Cancer Institute
Contact: Site Public Contact
Email: askroswell@roswellpark.org
New York
Mount Sinai Hospital
Contact: Site Public Contact
Email: CCTO@mssm.edu
OH
Dayton
Dayton Physician LLC - Englewood
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Kettering
Kettering Medical Center
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org
Toledo
Toledo Clinic Cancer Centers-Toledo
Contact: Site Public Contact
OK
Oklahoma City
University of Oklahoma Health Sciences Center
Contact: Site Public Contact
Email: ou-clinical-trials@ouhsc.edu
OR
Ontario
Saint Alphonsus Cancer Care 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
SD
Sioux Falls
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
TX
Houston
M D Anderson Cancer Center
Contact: Site Public Contact
Email: askmdanderson@mdanderson.org
WA
Edmonds
Swedish Cancer Institute-Edmonds
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Issaquah
Swedish Cancer Institute-Issaquah
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Renton
Valley Medical Center
Contact: Site Public Contact
Email: research@valleymed.org
Seattle
Swedish Medical Center-First Hill
Contact: Site Public Contact
Email: PCRC-NCORP@Swedish.org
Yakima
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Contact: Site Public Contact
Email: Memorial-ClinicalTrials@yvmh.org
WI
Appleton
ThedaCare Regional Cancer Center
Contact: Site Public Contact
Email: ResearchDept@thedacare.org
Grafton
Aurora Cancer Care-Grafton
Contact: Site Public Contact
Email: ncorp@aurora.org
Green Bay
Aurora BayCare Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
La Crosse
Gundersen Lutheran Medical Center
Contact: Site Public Contact
Email: cancerctr@gundersenhealth.org
Madison
University of Wisconsin Carbone Cancer Center - University Hospital
Contact: Site Public Contact
Email: clinicaltrials@cancer.wisc.edu
Marinette
Aurora Bay Area Medical Group-Marinette
Contact: Site Public Contact
Email: ncorp@aurora.org
Milwaukee
Aurora Saint Luke's Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Aurora Sinai Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Contact: Site Public Contact
Email: ncorp@aurora.org
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Contact: Site Public Contact
Email: ncorp@aurora.org
Summit
Aurora Medical Center in Summit
Contact: Site Public Contact
Email: ncorp@aurora.org
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Contact: Site Public Contact
Email: ncorp@aurora.org
Wauwatosa
Aurora Cancer Care-Milwaukee West
Contact: Site Public Contact
Email: ncorp@aurora.org
West Allis
Aurora West Allis Medical Center
Contact: Site Public Contact
Email: ncorp@aurora.org
PRIMARY OBJECTIVE: I. To evaluate the proportion of patients with taxane-refractory advanced malignancies who have objective responses (OR) to treatment with nilotinib hydrochloride monohydrate (nilotinib) and paclitaxel. SECONDARY OBJECTIVE: I. Collect tissue and provide it to the ComboMATCH registration protocol to assess concordance between the diagnostic tumor mutation profile generated by the designated laboratories, the pre-treatment biopsy mutation profile, and the pre-treatment circulating tumor deoxyribonucleic acid (ctDNA) mutation profile from plasma, as described in ComboMATCH registration protocol. For this treatment substudy, the outcome objective will be to report the proportion of cases providing sufficient tissue for that integrated scientific activity in the ComboMATCH registration protocol. EXPLORATORY OBJECTIVES: I. To evaluate progression free survival (PFS) at 6 months on study agents. II. To identify genomic and transcriptomic determinants of response and resistance in tumor biopsy specimens and cell-free deoxyribonucleic acid (DNA). OUTLINE: Patients receive nilotinib hydrochloride monohydrate orally (PO) twice daily (BID) on days 1-28 and paclitaxel intravenously (IV) over 1 hour on days 1, 8, and 15 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) throughout the study. Patients also undergo collection of blood samples and tumor biopsy on study. After completion of study treatment, patients are followed until disease progression, and for survival for 3 years from registration.
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. This trial is part of the ComboMATCH precision medicine intiative.