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Imatinib Mesylate in Treating Patients With Gastrointestinal Stromal Tumor That Has Been Completely Removed During Surgery
This study is ongoing, but not recruiting participants.
First Received: October 11, 2001   Last Updated: February 6, 2009   History of Changes
Sponsor: American College of Surgeons
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00025246
  Purpose

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: This phase II trial is studying how well imatinib mesylate works in treating patients with gastrointestinal stromal tumor that was completely removed during surgery.


Condition Intervention Phase
Gastrointestinal Stromal Tumor
Drug: imatinib mesylate
Procedure: adjuvant therapy
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Study of Adjuvant STI571 Therapy in Patients Following Completely Resected High-Risk Primary Gastrointestinal Stromal Tumor (GIST)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2001
Detailed Description:

OBJECTIVES:

  • Determine survival of patients with completely resected high-risk primary gastrointestinal stromal tumor treated with adjuvant imatinib mesylate.
  • Determine the 2- and 5-year rates of recurrence in patients treated with this drug.
  • Determine the toxicity of this drug in these patients.

OUTLINE: Patients receive oral imatinib mesylate daily beginning within 84 days of surgical resection. Treatment continues for 1 year in the absence of disease recurrence or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 89 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed high-risk primary gastrointestinal stromal tumor

    • High-risk is defined as any of the following:

      • Tumor at least 10 cm in greatest dimension
      • Presence of tumor rupture before or during surgery
      • Intraperitoneal hemorrhage
      • Multifocal intraperitoneal tumors
  • Complete gross tumor resection performed within the past 70 days

    • Includes R0 (negative microscopic margins) and R1 (positive microscopic margins) resection
  • Kit protein positive
  • No residual disease on CT scan or MRI of the abdomen or pelvis

PATIENT CHARACTERISTICS:

Age:

  • 16 and over

Performance status:

  • ECOG 0-2 OR
  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST/ALT no greater than 2.5 times ULN

Renal:

  • Creatinine no greater than 1.5 times ULN

Cardiovascular:

  • No New York Heart Association class III or IV heart disease

Other:

  • No active infection requiring antibiotics within the past 14 days
  • No other prior malignancy within the past 5 years except:

    • Effectively treated basal cell or squamous cell skin cancer
    • Carcinoma in situ of the cervix effectively treated by surgery alone
    • Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by surgery alone
  • At low risk for recurrence of curatively treated prior malignancies
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective barrier-method contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No post-operative chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No post-operative radiotherapy

Surgery:

  • See Disease Characteristics

Other:

  • No prior imatinib mesylate
  • No post-operative investigational treatment
  • No concurrent full-dose warfarin
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00025246

  Hide Study Locations
Locations
United States, Alabama
Mobile Infirmary Medical Center
Mobile, Alabama, United States, 36640-0460
United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
Veterans Affairs Medical Center - San Francisco
San Francisco, California, United States, 94121-1598
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94122-2722
University of California Davis Cancer Center
Sacramento, California, United States, 95817
Community Hospital of the Monterey Peninsula
Monterey, California, United States, 93940
United States, Colorado
University of Colorado Cancer Center
Denver, Colorado, United States, 80010
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
Lakeland Regional Medical Center
Lakeland, Florida, United States, 33804
Shands Hospital and Clinics, University of Florida
Gainesville, Florida, United States, 32610-100277
University of Florida - Gainesville
Gainesville, Florida, United States, 32610-0277
Watson Clinic
Lakeland, Florida, United States, 33805
United States, Hawaii
Department of Surgery
Honolulu, Hawaii, United States, 96813
United States, Illinois
Evanston Northwestern Health Care - Evanston Hospital
Evanston, Illinois, United States, 60201
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62794-9230
St. John's Hospital
Springfield, Illinois, United States, 62769
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Indiana
St. Francis Hospital and Health Centers
Beech Grove, Indiana, United States, 46107
United States, Kentucky
Central Baptist Hospital
Lexington, Kentucky, United States, 40503-9985
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
St. Agnes Healthcare
Baltimore, Maryland, United States, 21229
United States, Mississippi
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, United States, 39534-2576
United States, Missouri
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, United States, 65203
St. Louis University Health Sciences Center
Saint Louis, Missouri, United States, 63110-0250
United States, Nebraska
Creighton University School of Medicine
Omaha, Nebraska, United States, 68131
United States, New Hampshire
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New York
James P. Wilmot Cancer Center
Rochester, New York, United States, 14642
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Orange Regional Medical Center - Horton Campus
Middletown, New York, United States, 10940-4199
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
State University of New York Health Science Center at Brooklyn College of Medicine
Brooklyn, New York, United States, 11203
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, United States, 27599-7295
United States, Ohio
Akron City Hospital
Akron, Ohio, United States, 44309
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210-1240
Good Samaritan Hospital
Dayton, Ohio, United States, 45406-1891
Greene Memorial Hospital
Xenia, Ohio, United States, 45385
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Miami Valley Hospital
Troy, Ohio, United States, 45373
United States, Oregon
Oregon Cancer Institute
Portland, Oregon, United States, 97239
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
United States, Tennessee
Associates in Oncology and Hematology
Chattanooga, Tennessee, United States, 37404
Parkridge Medical Center
Chattanooga, Tennessee, United States, 37404
University Surgical Associates
Chattanooga, Tennessee, United States, 37404
United States, Texas
Presbyterian Hospital of Dallas
Dallas, Texas, United States, 75231
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030-4009
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Cottonwood Hospital Medical Center
Murray, Utah, United States, 84107
Dixie Regional Medical Center
Saint George, Utah, United States, 84770
American Fork Hospital
American Fork, Utah, United States, 84003
Latter Day Saints Hospital
Salt Lake City, Utah, United States, 84143
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403
Ogden Regional Medical Center
Ogden, Utah, United States, 84405
Utah Valley Regional Medical Center - Provo
Provo, Utah, United States, 84604
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195-6043
United States, Wisconsin
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, United States, 54449
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States, 53226
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Sponsors and Collaborators
American College of Surgeons
Investigators
Study Chair: Ronald DeMatteo, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Publications:
DeMatteo RP, Owzar K, Antonescu CR, et al.: Efficacy of adjuvant imatinib mesylate following complete resection of localized, primary gastrointestinal stromal tumor (GIST) at high risk of recurrence: the U.S. Intergroup phase II trial ACOSOG Z9000. [Abstract] American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, 25-27 January 2008, Orlando, FL. A-8, 2008.
Dematteo RP, Antonescu CR, Chadaram V, et al.: Adjuvant imatinib mesylate in patients with primary high risk gastrointestinal stromal tumor (GIST) following complete resection: safety results from the U.S. intergroup phase II trial ACOSOG Z9000. [Abstract] J Clin Oncol 23 (Suppl 16): A-9009, 818s, 2005.

Study ID Numbers: CDR0000068942, ACOSOG-Z9000, CWRU-020313
Study First Received: October 11, 2001
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00025246     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
gastrointestinal stromal tumor

Additional relevant MeSH terms:
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Gastrointestinal Diseases
Physiological Effects of Drugs
Adjuvants, Immunologic
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions
Imatinib
Neoplasms
Neoplasms by Site
Digestive System Diseases
Therapeutic Uses
Gastrointestinal Neoplasms
Gastrointestinal Stromal Tumors

ClinicalTrials.gov processed this record on November 27, 2009