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| Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00041340 |
Purpose
RATIONALE: Imatinib mesylate may interfere with the growth of tumor cells by blocking certain enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have stage IV colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: imatinib mesylate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Study Of Gleevec (Imatinib Mesylate Formerly Known As(STI571) (NSC #716051) In Patients With Colorectal Cancer Stage IV |
| Estimated Enrollment: | 37 |
| Study Start Date: | May 2002 |
OBJECTIVES:
OUTLINE: Patients receive oral imatinib mesylate twice daily. Treatment continues for 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease or better continue therapy until disease progression or 1 year after complete response.
PROJECTED ACCRUAL: A total of 14-37 patients will be accrued for this study within 5-37 months.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least one unidimensionally measurable lesion
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Texas | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Razelle Kurzrock, MD | M.D. Anderson Cancer Center |
More Information
| Study ID Numbers: | CDR0000069475, MDA-ID-01557, NCI-5652 |
| Study First Received: | July 8, 2002 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00041340 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV colon cancer stage IV rectal cancer recurrent colon cancer recurrent rectal cancer |
|
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Rectal Neoplasm Intestinal Diseases Protein Kinase Inhibitors Rectal Diseases |
Recurrence Intestinal Neoplasms Imatinib Digestive System Diseases Rectal Cancer Gastrointestinal Neoplasms Colorectal Neoplasms |
|
Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Colonic Diseases Enzyme Inhibitors Intestinal Diseases Rectal Diseases Protein Kinase Inhibitors |
Pharmacologic Actions Intestinal Neoplasms Imatinib Neoplasms Neoplasms by Site Digestive System Diseases Therapeutic Uses Gastrointestinal Neoplasms Colorectal Neoplasms |