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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00039585 |
Purpose
RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
PURPOSE: Phase II trial to determine the effectiveness of imatinib mesylate in treating patients who have refractory or relapsed ovarian epithelial, fallopian tube, or primary peritoneal cancer, or ovarian low malignant potential tumor.
| Condition | Intervention | Phase |
|---|---|---|
|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: imatinib mesylate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | Phase II Clinical Trial With Proteomic Profiling Of Imatinib Mesylate (Gleevec; STI571), A PDGFR And C-Kit Inhibitor, In Patients With Refractory Or Relapsed Epithelial Ovarian Cancer, Fallopian Tube And Primary Peritoneal Cancer |
| Study Start Date: | May 2002 |
| Primary Completion Date: | February 2006 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Patients receive oral imatinib mesylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: Up to 47 patients will be accrued for this study within 12-20 months.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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 therapeutic warfarin
Contacts and Locations| United States, Maryland | |
| NCI - Center for Cancer Research | |
| Bethesda, Maryland, United States, 20892-1906 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Elise C. Kohn, MD | National Cancer Institute (NCI) |
| Investigator: | Virginia Kwitkowski, MS, RN, CS, CRNP | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000069403, NCI-02-C-0190, NCI-5672A |
| Study First Received: | June 6, 2002 |
| Last Updated: | December 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00039585 History of Changes |
| Health Authority: | United States: Federal Government |
|
recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer borderline ovarian surface epithelial-stromal tumor |
|
Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Urogenital Neoplasms Ovarian Diseases Protein Kinase Inhibitors Genital Diseases, Female Neoplasms by Site Therapeutic Uses Peritoneal Diseases Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms |
Genital Neoplasms, Female Endocrine System Diseases Enzyme Inhibitors Abdominal Neoplasms Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Imatinib Neoplasms Digestive System Diseases Peritoneal Neoplasms |