A Phase II Study of Gleevec in Patients With Recurrent Platinum-Resistant, Taxane-Resistant Epithelial Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall Response Rate (ORR)
ORR = participant proportion with responsive disease: Complete Response (CR): disappearance all clinically detectable malignant disease for at least 4 weeks, no new lesions; Partial Response (PR): >/= 50% decrease sum of products of perpendicular diameters of all measurable lesions for at least 4 weeks; Stable Disease: does not qualify for CR, PR or progression. Progressive Disease: a 25% or > increase in sum of products of measurable lesions over smallest sum observed, OR reappearance of lesion which had disappeared, OR appearance of new lesion/site. Response determined every 6 week cycle.
6 weeks with re-evaluation every 6 weeks or until disease progression
David Gershenson, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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