Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00030706
Status:
COMPLETED
Last Update Posted:
2018-09-28
First Post:
2002-02-14
Brief Title:
Ixabepilone in Treating Patients With Relapsed andor Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Phase II Study Of Epothilone B Analogue BMS-247550 In Relapse AndOr Refractory Stage III Or IV Ovarian Epithelial Cancer Following Front-Line Treatment With Platinum Plus Taxane-Based Chemotherapy
Status:
COMPLETED
Status Verified Date:
2018-09
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:
RATIONALE Drugs used in chemotherapy such as ixabepilone work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of ixabepilone in treating patients who have relapsed andor refractory stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer
PURPOSE Phase II trial to study the effectiveness of ixabepilone in treating patients who have relapsed andor refractory stage III or stage IV ovarian epithelial cancer or primary peritoneal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of ixabepilone in terms of clinical response and progression-free survival in patients with relapsed andor refractory stage III or IV ovarian epithelial or primary peritoneal cancer
Determine the nature and degree of toxicity of this drug in these patients
Secondary
Correlate pre-ixabepilone survivin mRNA and protein levels in patient-derived ovarian cancer cells with quality of response ie at least partial response vs no response
Correlate CYP3A4 3A41B 3A5 3A51 and 3A7 ER6 p variation allelic polymorphisms with parent drug kinetic parameters toxicity and efficacy of this drug in these patients
OUTLINE This is a multicenter study
Patients receive ixabepilone IV over 1 hour once weekly on weeks 1-3 Treatment repeats every 4 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 12 months
Primary
Determine the antitumor activity of ixabepilone in terms of clinical response and progression-free survival in patients with relapsed andor refractory stage III or IV ovarian epithelial or primary peritoneal cancer
Determine the nature and degree of toxicity of this drug in these patients
Secondary
Correlate pre-ixabepilone survivin mRNA and protein levels in patient-derived ovarian cancer cells with quality of response ie at least partial response vs no response
Correlate CYP3A4 3A41B 3A5 3A51 and 3A7 ER6 p variation allelic polymorphisms with parent drug kinetic parameters toxicity and efficacy of this drug in these patients
OUTLINE This is a multicenter study
Patients receive ixabepilone IV over 1 hour once weekly on weeks 1-3 Treatment repeats every 4 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 12-37 patients will be accrued for this study within 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-3632 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA013330 |
| P30CA013330 | NIH | None | None |
| AECM-3632 | None | None | None |
| MCC-12602 | None | None | None |