Imatinib Mesylate (Gleevec®, STI571) in Combination With Docetaxel (Taxotere) for the Treatment of Advanced, Platinum-Refractory Ovarian Cancer and Primary Peritoneal Carcinomatosis: Hoosier Oncology Group GYN03-62
OUTLINE: This is a multi-center study.
Submit tumor and serum samples for central review
- Imatinib 600 mg (orally qd);
- Docetaxel 30mg/m2 (4 of 6 weeks);1 cycle = 6 weeks
- Evaluate every other cycle
Each cycle will begin only when the granulocyte count is > 1,500/mm3 and the platelet count
is > 100,000/mm3 and any other treatment-related toxicities are < grade 1. If the toxicity
is not resolved to grade 0 or 1 after three weeks, the patient will be withdrawn from the
study. For days 8, 15, and 22 patients must have an absolute neutrophil count > 1,000/mm3
or greater and platelet count > 75,000/mm3. Imatinib mesylate can be administered if
platelets >20,000 and ANC >500.
ECOG performance status 0 or 1
- ANC > 1,500/mm3·
- Platelets > 100,000 mm3·
- Hgb > 8g/dl
- Total bilirubin < ULN·
- Maximum Alk Phos: >2.5x but < 5x ULN
- Creatinine < 1.5 x ULN·(by Cockroft and Gault)
- No grade III/IV cardiac problems as defined by the New York Heart Association Criteria.
(i.e., congestive heart failure, myocardial infarction within 6 months prior to
beginning protocol therapy)
- Not specified
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
· To determine response rate (CR, PR and SD) of patients with advanced, platinum-refractory ovarian cancer, whose tumors over-express PDGFR or c-kit receiving imatinib mesylate in combination with docetaxel.
Daniela Matei, M.D.
Hoosier Oncology Group, LLC
United States: Institutional Review Board
HOG GYN 03-62
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Arnett Cancer Care||Lafayette, Indiana 47904|
|Medical & Surgical Specialists, LLC||Galesburg, Illinois 61401|
|Oncology Hematology Associates of SW Indiana||Evansville, Indiana 47714|
|Elkhart Clinic||Elkhart, Indiana 46515|
|Medical Consultants, P.C.||Muncie, Indiana 47303|
|Center for Cancer Care, Inc., P.C.||New Albany, Indiana 47150|
|AP&S Clinic||Terre Haute, Indiana 47804|
|Fort Wayne Oncology & Hematology, Inc||Fort Wayne, Indiana 46815|