Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor
NCT ID: NCT00009906
Last Updated: 2014-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
748 participants
INTERVENTIONAL
2000-12-31
2014-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm I (imatinib mesylate)
Patients receive oral imatinib mesylate once daily.
Imatinib Mesylate
Given orally
Arm II (imatinib mesylate)
Patients receive oral imatinib mesylate twice daily.
Imatinib Mesylate
Given orally
Interventions
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Imatinib Mesylate
Given orally
Eligibility Criteria
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Inclusion 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
15 Years
ALL
No
Sponsors
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Eastern Cooperative Oncology Group
NETWORK
SWOG Cancer Research Network
NETWORK
NCIC Clinical Trials Group
NETWORK
National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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George Demetri
Role: PRINCIPAL_INVESTIGATOR
SWOG Cancer Research Network
Locations
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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 D.C., 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
Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield
Springfield, Missouri, United States
Saint Louis Cancer and Breast Institute-South City
St Louis, Missouri, United States
Barnes-Jewish Hospital
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, 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
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
Albert Einstein College of Medicine
The Bronx, New York, United States
Montefiore Medical Center - Moses Campus
The Bronx, 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 Corners, 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
Countries
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References
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Heinrich MC, Rankin C, Blanke CD, Demetri GD, Borden EC, Ryan CW, von Mehren M, Blackstein ME, Priebat DA, Tap WD, Maki RG, Corless CL, Fletcher JA, Owzar K, Crowley JJ, Benjamin RS, Baker LH. Correlation of Long-term Results of Imatinib in Advanced Gastrointestinal Stromal Tumors With Next-Generation Sequencing Results: Analysis of Phase 3 SWOG Intergroup Trial S0033. JAMA Oncol. 2017 Jul 1;3(7):944-952. doi: 10.1001/jamaoncol.2016.6728.
Other Identifiers
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NCI-2012-02372
Identifier Type: REGISTRY
Identifier Source: secondary_id
S0033
Identifier Type: -
Identifier Source: secondary_id
INT-S0033
Identifier Type: -
Identifier Source: secondary_id
CDR0000068422
Identifier Type: -
Identifier Source: secondary_id
CAN-NCIC-S0033
Identifier Type: -
Identifier Source: secondary_id
CLB-80004
Identifier Type: -
Identifier Source: secondary_id
SWOG-S0033
Identifier Type: -
Identifier Source: secondary_id
E-S0033
Identifier Type: -
Identifier Source: secondary_id
S0033
Identifier Type: OTHER
Identifier Source: secondary_id
S0033
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2012-02372
Identifier Type: -
Identifier Source: org_study_id