Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216112
Status:
COMPLETED
Last Update Posted:
2016-02-19
First Post:
2005-09-12
Brief Title:
Imatinib Mesylate in Combination With Docetaxel for Advanced Platinum-Refractory Ovarian Cancer
Sponsor:
Daniela Matei MD
Organization:
Hoosier Cancer Research Network
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 30mgm2 4 of 6 weeks1 cycle 6 weeks
Evaluate every other cycle
Each cycle will begin only when the granulocyte count is 1500mm3 and the platelet count is 100000mm3 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toxicities are grade 1 If the toxicity is not resolved to grade 0 or 1 after three weeks the patient will be withdrawn from the study For days 8 15 and 22 patients must have an absolute neutrophil count 1000mm3 or greater and platelet count 75000mm3 Imatinib mesylate can be administered if platelets 20000 and ANC 500
ECOG performance status 0 or 1
Hematopoietic
ANC 1500mm3
Platelets 100000 mm3
Hgb 8gdl
Hepatic
Albumin3gmdL
Total bilirubin ULN
Maximum Alk Phos 25x but 5x ULN
Renal
Creatinine 15 x ULNby Cockroft and Gault
Cardiovascular
No grade IIIIV cardiac problems as defined by the New York Heart Association Criteria ie 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 30mgm2 4 of 6 weeks1 cycle 6 weeks
Evaluate every other cycle
Each cycle will begin only when the granulocyte count is 1500mm3 and the platelet count is 100000mm3 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 1000mm3 or greater and platelet count 75000mm3 Imatinib mesylate can be administered if platelets 20000 and ANC 500
ECOG performance status 0 or 1
Hematopoietic
ANC 1500mm3
Platelets 100000 mm3
Hgb 8gdl
Hepatic
Albumin3gmdL
Total bilirubin ULN
Maximum Alk Phos 25x but 5x ULN
Renal
Creatinine 15 x ULNby Cockroft and Gault
Cardiovascular
No grade IIIIV cardiac problems as defined by the New York Heart Association Criteria ie congestive heart failure myocardial infarction within 6 months prior to beginning protocol therapy
Pulmonary
Not specified
Study Oversight
Has Oversight DMC:
None
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?:
None