Ovarian Cancer Clinical Trial
Official title:
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
Imatinib mesylate is an inhibitor of the receptor tyrosine kinases for platelet-derived
growth factor (PDGF) and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated
cellular events. Docetaxel promotes cell growth arrest by inhibiting the deassembly of
tubulin and by promoting at the same time microtubule assembly. Docetaxel has single agent
activity in ovarian cancer with response rates of 30-40% in the platinum refractory setting.
The combination of imatinib mesylate and docetaxel has potential synergistic effects, based
on previous reports showing synergy in-vitro and in-vivo between PDGFR inhibitors or PI3K
inhibitors and taxane chemotherapy.
This trial will investigate the efficacy the combination of imatinib mesylate and docetaxel
in treating patients with advanced, platinum-refractory ovarian cancer and primary
peritoneal carcinomatosis.
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is not resolved to grade 0 or 1 after three weeks, the patient will be withdrawn from the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
Hematopoietic:·
- ANC > 1,500/mm3·
- Platelets > 100,000 mm3·
- Hgb > 8g/dl
Hepatic:·
- Albumin>3gm/dL·
- Total bilirubin < ULN·
- Maximum Alk Phos: >2.5x but < 5x ULN
Renal:·
- Creatinine < 1.5 x ULN·(by Cockroft and Gault)
Cardiovascular:·
- 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)
Pulmonary:·
- Not specified
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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