Spots Global Cancer Trial Database for Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor
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Trial Identification
Brief Title: Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor
Official Title: Phase III Randomized, Intergroup Trial Assessing the Clinical Activity Of STI-571 at Two Dose Levels in Patients With Unresectable or Metastatic Gastrointestinal Stromal Tumors (GIST) Expressing the Kit Receptor Tyrosine Kinase (CD117)
Study ID: NCT00009906
Conditions
Interventions
Study Description
Brief Summary: Randomized phase III trial to compare the effectiveness of two different doses of STI571 in treating patients who have metastatic or unresectable gastrointestinal stromal tumor. STI571 may interfere with the growth of tumor cells and may be an effective treatment for cancer. It is not yet known which dose of STI571 is more effective in treating gastrointestinal stromal tumors.
Detailed Description: PRIMARY OBJECTIVES: I. Compare the overall and progression-free survival of patients with CD117-expressing metastatic or unresectable gastrointestinal stromal tumor treated with two different doses of imatinib mesylate. II. Compare the confirmed, unconfirmed, complete, and partial response rates in patients treated with these regimens. III. Compare the toxic effects of these regimens in these patients. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. Arm I: Patients receive oral imatinib mesylate once daily. Arm II: Patients receive oral imatinib mesylate twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients in arm I with progressive disease may cross over to arm II and receive treatment in the absence of further disease progression. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study within 24 months.
Keywords
Eligibility
Minimum Age: 15 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Western Regional CCOP, Phoenix, Arizona, United States
University of Arizona Health Sciences Center, Tucson, Arizona, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Highlands Oncology Group-Rogers, Rogers, Arkansas, United States
City of Hope Comprehensive Cancer Center, Duarte, California, United States
Long Beach Community Hospital, Long Beach, California, United States
University of Southern California/Norris Cancer Center, Los Angeles, California, United States
University of California at Los Angeles Health System, Los Angeles, California, United States
Sutter Cancer Research Consortium, Novato, California, United States
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States
Kaiser Permanente - Sacramento, Sacramento, California, United States
University of California San Diego, San Diego, California, United States
UCSF Medical Center-Mount Zion, San Francisco, California, United States
Santa Rosa Memorial Hospital, Sana Rosa, California, United States
Stanford University Hospitals and Clinics, Stanford, California, United States
Presbyterian - Saint Lukes Medical Center - Health One, Denver, Colorado, United States
Rose Medical Center, Denver, Colorado, United States
Swedish Medical Center, Englewood, Colorado, United States
Poudre Valley Hospital, Fort Collins, Colorado, United States
Saint Mary Corwin Medical Center, Pueblo, Colorado, United States
Middlesex Hospital, Middletown, Connecticut, United States
MedStar Oncology Network, Washington, District of Columbia, United States
Mayo Clinic in Florida, Jacksonville, Florida, United States
Hematology Oncology Associates, Lake Worth, Florida, United States
Florida Hospital Orlando, Orlando, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Phoebe Putney Memorial Hospital, Albany, Georgia, United States
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
Atlanta Regional CCOP, Atlanta, Georgia, United States
Medical Center of Central Georgia, Macon, Georgia, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Hematology and Oncology Associates, Chicago, Illinois, United States
Northwestern University, Chicago, Illinois, United States
Jesse Brown Veterans Affairs Medical Center, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
University of Illinois, Chicago, Illinois, United States
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
Central Illinois CCOP, Decatur, Illinois, United States
Alexian Brothers Medical and Cancer Center, Elk Grove Village, Illinois, United States
NorthShore University HealthSystem-Evanston Hospital, Evanston, Illinois, United States
Loyola University Medical Center, Maywood, Illinois, United States
Mid-Illinois Hematology Oncology Associates, Normal, Illinois, United States
Advocate Lutheran General Hospital., Park Ridge, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
IU Health Methodist Hospital, Indianapolis, Indiana, United States
McFarland Clinic PC-William R Bliss Cancer Center, Ames, Iowa, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Kansas City CCOP, Prairie Village, Kansas, United States
Stormont-Vail Regional Health Center, Topeka, Kansas, United States
Our Lady Bellefonte Hospital, Ashland, Kentucky, United States
Louisiana State University Health Science Center, New Orleans, Louisiana, United States
Sinai Hospital of Baltimore, Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Michigan Cancer Research Consortium Community Clinical Oncology Program, Ann Arbor, Michigan, United States
University of Michigan University Hospital, Ann Arbor, Michigan, United States
Oakwood Hospital and Medical Center, Dearborn, Michigan, United States
Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Grand Rapids Clinical Oncology Program, Grand Rapids, Michigan, United States
West Michigan Cancer Center, Kalamazoo, Michigan, United States
Marquette General Hospital, Marquette, Michigan, United States
Unity Hospital, Fridley, Minnesota, United States
University of Minnesota Medical Center-Fairview, Minneapolis, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
Mayo Clinic, Rochester, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
University of Mississippi Medical Center, Jackson, Mississippi, United States
Saint Joseph's Health Center, Saint Charles, Missouri, United States
Saint Louis Cancer and Breast Institute-South City, Saint Louis, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield, Springfield, Missouri, United States
Alegent Health Immanuel Medical Center, Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center, Lebanon, New Hampshire, United States
Hackensack University Medical CCOP, Hackensack, New Jersey, United States
Saint Barnabas Medical Center, Livingston, New Jersey, United States
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
University of New Mexico, Albuquerque, New Mexico, United States
Albert Einstein College of Medicine, Bronx, New York, United States
Montefiore Medical Center - Moses Campus, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Winthrop University Hospital, Mineola, New York, United States
Beth Israel Medical Center, New York, New York, United States
New York University Langone Medical Center, New York, New York, United States
Columbia University Medical Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
University of North Carolina, Chapel Hill, North Carolina, United States
Duke University Medical Center, Durham, North Carolina, United States
Southeast Cancer Control Consortium CCOP, Winston-Salem, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Roger Maris Cancer Center, Fargo, North Dakota, United States
Case Western Reserve University, Cleveland, Ohio, United States
Cleveland Clinic Foundation, Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Columbus CCOP, Columbus, Ohio, United States
Dayton CCOP, Dayton, Ohio, United States
Saint Rita's Medical Center, Lima, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Sky Lakes Medical Center - Cancer Treatment Center, Klamath Falls, Oregon, United States
Western Oncology Research Consortium, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Salem Hospital, Salem, Oregon, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Mercy Fitzgerald Hospital, Darby, Pennsylvania, United States
Delaware County Memorial Hospital, Drexel Hill, Pennsylvania, United States
University of Pennsylvania/Abramson Cancer Center, Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Aria Health-Torresdale Campus, Philadelphia, Pennsylvania, United States
Albert Einstein Medical Center, Philadelphia, Pennsylvania, United States
Rhode Island Hospital, Providence, Rhode Island, United States
Upstate Carolina CCOP, Spartanburg, South Carolina, United States
Baptist Memorial Hospital and Cancer Center-Memphis, Memphis, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
M D Anderson Cancer Center, Houston, Texas, United States
Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States
Central Vermont Medical Center, Barre, Vermont, United States
Central Vermont Medical Center/National Life Cancer Treatment, Berlin, Vermont, United States
Rutland Regional Medical Center, Rutland, Vermont, United States
Virginia Oncology Associates-Hampton, Hampton, Virginia, United States
Virginia Mason CCOP, Seattle, Washington, United States
Group Health, Seattle, Washington, United States
Cancer Care Northwest - Spokane South, Spokane, Washington, United States
Northwest CCOP, Tacoma, Washington, United States
Saint Vincent Hospital, Green Bay, Wisconsin, United States
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States
Marshfield Clinic, Marshfield, Wisconsin, United States
Tom Baker Cancer Centre, Calgary, Alberta, Canada
Cross Cancer Institute, Edmonton, Alberta, Canada
BCCA-Vancouver Cancer Centre, Vancouver, British Columbia, Canada
Hamilton and District Urology Association McMaster Institute, Hamilton, Ontario, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Ottawa Health Research Institute-General Division, Ottawa, Ontario, Canada
Mount Sinai Hospital, Toronto, Ontario, Canada
CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada
McGill University Department of Oncology, Montreal, Quebec, Canada
San Juan Veterans Affairs Medical Center, San Juan, , Puerto Rico
San Juan City Hospital, San Juan, , Puerto Rico
Contact Details
Name: George Demetri
Affiliation: SWOG Cancer Research Network
Role: PRINCIPAL_INVESTIGATOR
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