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Tracking Information | |||||
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First Received Date † | September 7, 2004 | ||||
Last Updated Date | April 4, 2009 | ||||
Start Date † | December 2005 | ||||
Current Primary Outcome Measures † |
Response rate as determined by computer tomography measurements every 2 months [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00091078 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Oblimersen and Imatinib Mesylate in Treating Patients With Advanced Gastrointestinal Stromal Tumors That Cannot Be Removed By Surgery | ||||
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 | ||||
Brief Summary | 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. |
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Detailed Description | 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. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † | Gastrointestinal Stromal Tumor | ||||
Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Estimated Enrollment † | 96 | ||||
Completion Date | |||||
Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
NOTE: **Widespread progression of all tumor foci
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00091078 | ||||
Responsible Party | |||||
Secondary IDs †† | MDA-2003-0761, NCI-6122 | ||||
Study Sponsor † | M.D. Anderson Cancer Center | ||||
Collaborators †† | National Cancer Institute (NCI) | ||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | December 2006 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |