Ovarian Cancer Clinical Trial
Official title:
A Phase II Study of Gleevec in Patients With Recurrent Platinum-Resistant, Taxane-Resistant Epithelial Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
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.
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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