Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
NCT ID:
NCT00216112
Brief Summary:
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.
Detailed Description:
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 If the toxicity is not resolved to grade 0 or 1 after three weeks, the patient will be withdrawn from the study.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
Study:
NCT00216112
Study Brief:
Protocol Section:
NCT00216112