Conditions: Ovarian Cancer
Keywords: Ovarian Cancer Primary Peritoneal Cancer Fallopian Tube Cancer Recurrent Platinum-Resistant Taxane-Resistant Epithelial Ovarian Cancer Imatinib Mesylate Gleevec STI571 Protein tyrosine kinase inhibitor
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 73
Healthy volunteers: no

Brief summary:
Primary Objectives:

1. To determine the efficacy of Gleevec in patients with recurrent platinum-resistant, taxane-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer whose tumor expresses either c-KIT, platelet-derived growth factor receptor (PDGRF), or ABL.
2. To determine the nature and degree of toxicity of Gleevec in this cohort of patients.

Detailed description:
Imatinib Mesylate is a new medication that blocks several proteins important in the development of cancer. Before going on study, potential participants will have their tumor tested for c-KIT, PDGFR, and ABL for positivity. Those participants who have at least one positive biomarker will be eligible for treatment.

Before treatment starts, participants will have a complete checkup, blood tests, chest x-ray, and heart function test. Women able to have children must have a negative blood pregnancy test. A blood sample (3 teaspoons) will be taken once a week during treatment and at the end of treatment. A complete exam will also be done at the end of treatment. Tumors will be measured by computed tomography (CT) scan every 6 weeks while one study and at the end of treatment.

Participants in this study will take Imatinib Mesylate by mouth in a single dose on a daily basis. Participants will be treated for 6 weeks, which is one cycle of therapy. After 6 weeks, participants will be evaluated for side effects and tumor response. The dose may be decreased for the next cycle if participants side effects. Participants will be removed from the study if the tumor gets worse. Participants may remain on the study as long as the tumor has not gotten worse and there are no intolerable side effects.

This is an investigational study. Imatinib Mesylate has been approved for chronic myelogenous leukemia patients. However this is an investigational study of Imatinib Mesylate in patients with ovarian, tubal, or peritoneal cancer. Participants may responsible for the cost of all or part of this drug. At least 24 and as many as 74 patients will take part in this study. All will be enrolled at M. D. Anderson.

Arms:
arm 1: 600 mg/day orally for 6 Weeks

Interventions: intervention 1: Imatinib Mesylate
Intervention descriptions: intervention 1: 600 mg by mouth daily for 6 Weeks

Protocol document: