Comparison of Two Different Doses of STI571 in Treating Patients With Metastatic or Unresectable Gastrointestinal Stromal Tumor

Gastrointestinal Stromal Tumor Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00009906
• Other study ID #: NCI-2012-02372
• Secondary ID: NCI-2012-02372S0
• Status: Terminated
• Phase: Phase 3
• First received: February 2, 2001
• Last updated: December 19, 2014
• Start date: December 2000
• Est. completion date: November 2014

Study information

• Verified date: June 2014
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 748
• Est. completion date: November 2014
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Imatinib Mesylate
Given orally

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
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	CHUM - Hopital Notre-Dame	Montreal	Quebec
Canada	McGill University Department of Oncology	Montreal	Quebec
Canada	Ottawa Health Research Institute-General Division	Ottawa	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	BCCA-Vancouver Cancer Centre	Vancouver	British Columbia
Puerto Rico	San Juan City Hospital	San Juan
Puerto Rico	San Juan Veterans Affairs Medical Center	San Juan
United States	Phoebe Putney Memorial Hospital	Albany	Georgia
United States	University of New Mexico	Albuquerque	New Mexico
United States	McFarland Clinic PC-William R Bliss Cancer Center	Ames	Iowa
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	Our Lady Bellefonte Hospital	Ashland	Kentucky
United States	Atlanta Regional CCOP	Atlanta	Georgia
United States	Emory University/Winship Cancer Institute	Atlanta	Georgia
United States	Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center	Baltimore	Maryland
United States	Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Central Vermont Medical Center	Barre	Vermont
United States	Central Vermont Medical Center/National Life Cancer Treatment	Berlin	Vermont
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts
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	University of North Carolina	Chapel Hill	North Carolina
United States	Hematology and Oncology Associates	Chicago	Illinois
United States	Jesse Brown Veterans Affairs Medical Center	Chicago	Illinois
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago Comprehensive Cancer Center	Chicago	Illinois
United States	University of Illinois	Chicago	Illinois
United States	Case Western Reserve University	Cleveland	Ohio
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Columbus CCOP	Columbus	Ohio
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Mercy Fitzgerald Hospital	Darby	Pennsylvania
United States	Dayton CCOP	Dayton	Ohio
United States	Oakwood Hospital and Medical Center	Dearborn	Michigan
United States	Central Illinois CCOP	Decatur	Illinois
United States	Presbyterian - Saint Lukes Medical Center - Health One	Denver	Colorado
United States	Rose Medical Center	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Wayne State University/Karmanos Cancer Institute	Detroit	Michigan
United States	Delaware County Memorial Hospital	Drexel Hill	Pennsylvania
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Duke University Medical Center	Durham	North Carolina
United States	Alexian Brothers Medical and Cancer Center	Elk Grove Village	Illinois
United States	Swedish Medical Center	Englewood	Colorado
United States	NorthShore University HealthSystem-Evanston Hospital	Evanston	Illinois
United States	Roger Maris Cancer Center	Fargo	North Dakota
United States	Poudre Valley Hospital	Fort Collins	Colorado
United States	Unity Hospital	Fridley	Minnesota
United States	Grand Rapids Clinical Oncology Program	Grand Rapids	Michigan
United States	Saint Vincent Hospital	Green Bay	Wisconsin
United States	Hackensack University Medical CCOP	Hackensack	New Jersey
United States	Virginia Oncology Associates-Hampton	Hampton	Virginia
United States	University of Hawaii Cancer Center	Honolulu	Hawaii
United States	M D Anderson Cancer Center	Houston	Texas
United States	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	IU Health Methodist Hospital	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Sky Lakes Medical Center - Cancer Treatment Center	Klamath Falls	Oregon
United States	Hematology Oncology Associates	Lake Worth	Florida
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Saint Rita's Medical Center	Lima	Ohio
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Saint Barnabas Medical Center	Livingston	New Jersey
United States	Long Beach Community Hospital	Long Beach	California
United States	University of California at Los Angeles Health System	Los Angeles	California
United States	University of Southern California/Norris Cancer Center	Los Angeles	California
United States	Medical Center of Central Georgia	Macon	Georgia
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Marquette General Hospital	Marquette	Michigan
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Loyola University Medical Center	Maywood	Illinois
United States	Baptist Memorial Hospital and Cancer Center-Memphis	Memphis	Tennessee
United States	Middlesex Hospital	Middletown	Connecticut
United States	Winthrop University Hospital	Mineola	New York
United States	University of Minnesota Medical Center-Fairview	Minneapolis	Minnesota
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Rutgers Cancer Institute of New Jersey	New Brunswick	New Jersey
United States	Louisiana State University Health Science Center	New Orleans	Louisiana
United States	Beth Israel 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	New York University Langone Medical Center	New York	New York
United States	Mid-Illinois Hematology Oncology Associates	Normal	Illinois
United States	Sutter Cancer Research Consortium	Novato	California
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Alegent Health Immanuel Medical Center	Omaha	Nebraska
United States	Florida Hospital Orlando	Orlando	Florida
United States	Advocate Lutheran General Hospital.	Park Ridge	Illinois
United States	Albert Einstein Medical Center	Philadelphia	Pennsylvania
United States	Aria Health-Torresdale Campus	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania/Abramson Cancer Center	Philadelphia	Pennsylvania
United States	Western Regional CCOP	Phoenix	Arizona
United States	Oregon Health and Science University	Portland	Oregon
United States	Western Oncology Research Consortium	Portland	Oregon
United States	Kansas City CCOP	Prairie Village	Kansas
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Saint Mary Corwin Medical Center	Pueblo	Colorado
United States	North Memorial Medical Health Center	Robbinsdale	Minnesota
United States	Mayo Clinic	Rochester	Minnesota
United States	Highlands Oncology Group-Rogers	Rogers	Arkansas
United States	Rutland Regional Medical Center	Rutland	Vermont
United States	Kaiser Permanente - Sacramento	Sacramento	California
United States	University of California Davis Comprehensive Cancer Center	Sacramento	California
United States	Saint Joseph's Health Center	Saint Charles	Missouri
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Missouri Baptist Medical Center	Saint Louis	Missouri
United States	Saint Louis Cancer and Breast Institute-South City	Saint Louis	Missouri
United States	Park Nicollet Clinic - Saint Louis Park	Saint Louis Park	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	Salem Hospital	Salem	Oregon
United States	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah
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	Group Health	Seattle	Washington
United States	Virginia Mason CCOP	Seattle	Washington
United States	Upstate Carolina CCOP	Spartanburg	South Carolina
United States	Cancer Care Northwest - Spokane South	Spokane	Washington
United States	Ozark Health Ventures LLC-Cancer Research for The Ozarks Springfield	Springfield	Missouri
United States	Stanford University Hospitals and Clinics	Stanford	California
United States	Northwest CCOP	Tacoma	Washington
United States	Moffitt Cancer Center	Tampa	Florida
United States	Stormont-Vail Regional Health Center	Topeka	Kansas
United States	University of Arizona Health Sciences Center	Tucson	Arizona
United States	Carle Cancer Center	Urbana	Illinois
United States	MedStar Oncology Network	Washington	District of Columbia
United States	Southeast Cancer Control Consortium CCOP	Winston-Salem	North Carolina
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)	Canadian Cancer Trials Group, Eastern Cooperative Oncology Group, Southwest Oncology Group

Countries where clinical trial is conducted

United States,  Canada,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival (OS)		Up to 3 years	No
Primary	Progression-free survival		From date of registration to date of first observation of progressive disease or death due to any cause, assessed up to 3 years	No
Primary	Toxicity defined as any grade 3 or greater organ toxicity, or any grade 4 or greater hematological toxicity as assessed by CTCAE version 2.0		Up to 3 year after completion of treatment	Yes