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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00091078 |
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Oblimersen may help imatinib mesylate kill more tumor cells by making tumor cells more sensitive to the drug.
PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with oblimersen works in treating patients with advanced gastrointestinal stromal tumor that cannot be removed by surgery.
Condition | Intervention | Phase |
---|---|---|
Gastrointestinal Stromal Tumor |
Drug: imatinib mesylate Drug: oblimersen |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase IIA Study to Determine the Safety and Efficacy of G3139 and Imatinib Mesylate in Patients With Refractory or Relapsed Gastrointestinal Stromal Tumors |
Estimated Enrollment: | 96 |
Study Start Date: | December 2005 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to extent of disease progression (limited vs generalized).
Patients receive oblimersen IV continuously on days 1-14. Patients also receive oral imatinib mesylate on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed for survival.
PROJECTED ACCRUAL: A total of 96 patients (48 per stratum) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed gastrointestinal stromal tumor
Limited* or generalized** disease progression after adequate therapy with imatinib mesylate (≥ 400 mg/day for at least 6 weeks), as defined by both of the following:
NOTE: **Widespread progression of all tumor foci
Measurable disease by CT scan
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent warfarin
United States, Massachusetts | |
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
University of Michigan Comprehensive Cancer Center | |
Ann Arbor, Michigan, United States, 48109-0942 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021-6007 | |
United States, Texas | |
M.D. Anderson Cancer Center at University of Texas | |
Houston, Texas, United States, 77030-4009 |
Study Chair: | Jonathan C. Trent, MD, PhD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000383199, MDA-2003-0761, NCI-6122 |
Study First Received: | September 7, 2004 |
Last Updated: | May 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00091078 |
Health Authority: | United States: Federal Government |
gastrointestinal stromal tumor |
Imatinib Digestive System Diseases Digestive System Neoplasms |
Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Protein Kinase Inhibitors Pharmacologic Actions |