Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT00216112
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Imatinib Mesylate in Combination With Docetaxel for Advanced, Platinum-Refractory Ovarian Cancer
Sponsor:
Daniela Matei, MD
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 If the toxicity is not resolved to grade 0 or 1 after three weeks, the patient will be withdrawn from the study.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
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: