Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor
Gastrointestinal Stromal Tumor
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumor
Eligibility Criteria
Inclusion Criteria: Patient must have a biopsy proven diagnosis of gastrointestinal stromal tumor (GIST) which is distantly metastatic or unresectable; tumors must meet BOTH of the following criteria: The primary must be of visceral or intra-abdominal origin All patients must have immunohistochemical documentation of KIT (CD117) expression by tumor documented by DAKO antibody staining for suggested methodology) Material must be submitted to the CALGB Pathology Coordinating Center for pathology review; it is strongly recommended that snap-frozen tissue biopsy and sera be stored for future submission whenever possible Patient must have measurable or non-measurable disease by conventional scan imaging (CT or MRI) or physical examination; tests used to assess disease must have been performed within 28 days prior to registration; if a target lesion has been previously embolized or irradiated, there must be objective evidence of progression to be considered for response assessment Patient must have an identified team (including a medical oncologist and a surgeon) to provide care Patient must not have known brain metastasis Patient must have a Zubrod performance status of 0 - 3 Patient must have resolution of transient toxicities from any prior therapy to =< grade 1 (NCI-CTC version 2.0) The patient must not have received chemotherapy, biologic therapy or any other investigational drug for any reason within 28 days prior to registration; patients must not have had a major surgery within 14 days prior to registration If day 14 or 28 falls on a weekend or holiday, the limit may be extended to the next working day In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday two weeks later would be considered day 14; this allows for efficient patient scheduling without exceeding the guidelines No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines At the time of patient registration, the treating institution's name and ID number must be provided to the Data Operations Center in Seattle in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base Patients on lower dose arm (Arm 1) will be allowed to increase the daily dose of STI-571 in the case of disease progression; if there is questionable disease progression, the treating investigator should contact the primary Study Coordinator, Dr. George Demetri at 617/632-3985 to review progression information and discuss treatment options
Sites / Locations
- Western Regional CCOP
- University of Arizona Health Sciences Center
- University of Arkansas for Medical Sciences
- Highlands Oncology Group-Rogers
- City of Hope Comprehensive Cancer Center
- Long Beach Community Hospital
- University of Southern California/Norris Cancer Center
- University of California at Los Angeles Health System
- Sutter Cancer Research Consortium
- University of California Davis Comprehensive Cancer Center
- Kaiser Permanente - Sacramento
- University of California San Diego
- UCSF Medical Center-Mount Zion
- Santa Rosa Memorial Hospital
- Stanford University Hospitals and Clinics
- Presbyterian - Saint Lukes Medical Center - Health One
- Rose Medical Center
- Swedish Medical Center
- Poudre Valley Hospital
- Saint Mary Corwin Medical Center
- Middlesex Hospital
- MedStar Oncology Network
- Mayo Clinic in Florida
- Hematology Oncology Associates
- Florida Hospital Orlando
- Moffitt Cancer Center
- Phoebe Putney Memorial Hospital
- Emory University/Winship Cancer Institute
- Atlanta Regional CCOP
- Medical Center of Central Georgia
- University of Hawaii Cancer Center
- Hematology and Oncology Associates
- Northwestern University
- Jesse Brown Veterans Affairs Medical Center
- Rush University Medical Center
- University of Illinois
- University of Chicago Comprehensive Cancer Center
- Central Illinois CCOP
- Alexian Brothers Medical and Cancer Center
- NorthShore University HealthSystem-Evanston Hospital
- Loyola University Medical Center
- Mid-Illinois Hematology Oncology Associates
- Advocate Lutheran General Hospital.
- Carle Cancer Center
- Indiana University/Melvin and Bren Simon Cancer Center
- IU Health Methodist Hospital
- McFarland Clinic PC-William R Bliss Cancer Center
- University of Kansas Medical Center
- Kansas City CCOP
- Stormont-Vail Regional Health Center
- Our Lady Bellefonte Hospital
- Louisiana State University Health Science Center
- Sinai Hospital of Baltimore
- Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
- Massachusetts General Hospital Cancer Center
- Dana-Farber Cancer Institute
- Beth Israel Deaconess Medical Center
- Michigan Cancer Research Consortium Community Clinical Oncology Program
- University of Michigan University Hospital
- Oakwood Hospital and Medical Center
- Wayne State University/Karmanos Cancer Institute
- Henry Ford Hospital
- Grand Rapids Clinical Oncology Program
- West Michigan Cancer Center
- Marquette General Hospital
- Unity Hospital
- University of Minnesota Medical Center-Fairview
- North Memorial Medical Health Center
- Mayo Clinic
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- University of Mississippi Medical Center
- Saint Joseph's Health Center
- Saint Louis Cancer and Breast Institute-South City
- Barnes-Jewish Hospital
- Missouri Baptist Medical Center
- Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
- Alegent Health Immanuel Medical Center
- Dartmouth Hitchcock Medical Center
- Hackensack University Medical CCOP
- Saint Barnabas Medical Center
- Rutgers Cancer Institute of New Jersey
- University of New Mexico
- Albert Einstein College of Medicine
- Montefiore Medical Center - Moses Campus
- Roswell Park Cancer Institute
- Winthrop University Hospital
- Beth Israel Medical Center
- New York University Langone Medical Center
- Columbia University Medical Center
- Memorial Sloan-Kettering Cancer Center
- University of North Carolina
- Duke University Medical Center
- Southeast Cancer Control Consortium CCOP
- Wake Forest University Health Sciences
- Roger Maris Cancer Center
- Case Western Reserve University
- Cleveland Clinic Foundation
- Ohio State University Comprehensive Cancer Center
- Columbus CCOP
- Dayton CCOP
- Saint Rita's Medical Center
- University of Oklahoma Health Sciences Center
- Sky Lakes Medical Center - Cancer Treatment Center
- Western Oncology Research Consortium
- Oregon Health and Science University
- Salem Hospital
- Geisinger Medical Center
- Mercy Fitzgerald Hospital
- Delaware County Memorial Hospital
- University of Pennsylvania/Abramson Cancer Center
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Aria Health-Torresdale Campus
- Albert Einstein Medical Center
- Rhode Island Hospital
- Upstate Carolina CCOP
- Baptist Memorial Hospital and Cancer Center-Memphis
- Vanderbilt-Ingram Cancer Center
- M D Anderson Cancer Center
- Huntsman Cancer Institute/University of Utah
- Central Vermont Medical Center
- Central Vermont Medical Center/National Life Cancer Treatment
- Rutland Regional Medical Center
- Virginia Oncology Associates-Hampton
- Virginia Mason CCOP
- Group Health
- Cancer Care Northwest - Spokane South
- Northwest CCOP
- Saint Vincent Hospital
- University of Wisconsin Hospital and Clinics
- Marshfield Clinic
- Tom Baker Cancer Centre
- Cross Cancer Institute
- BCCA-Vancouver Cancer Centre
- Hamilton and District Urology Association McMaster Institute
- Juravinski Cancer Centre at Hamilton Health Sciences
- London Regional Cancer Program
- Ottawa Health Research Institute-General Division
- Mount Sinai Hospital
- CHUM - Hopital Notre-Dame
- McGill University Department of Oncology
- San Juan Veterans Affairs Medical Center
- San Juan City Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm I (imatinib mesylate)
Arm II (imatinib mesylate)
Patients receive oral imatinib mesylate once daily.
Patients receive oral imatinib mesylate twice daily.