Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182767
Status:
COMPLETED
Last Update Posted:
2016-03-10
First Post:
2005-09-15
Brief Title:
Ixabepilone and Liposomal Doxorubicin in Advanced Ovarian Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of BMS-247550 and Pegylated Liposomal Doxorubicin Doxil in Patients With Advanced Epithelial Ovarian Cancer or Primary Peritoneal Cancer Who Have Been Previously Treated With a Platinum and a Taxane
Status:
COMPLETED
Status Verified Date:
2014-02
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:
This trial is studying the side effects and best dose of ixabepilone when given together with pegylated liposomal doxorubicin hydrochloride and to see how well they work in treating women with advanced ovarian epithelial primary peritoneal cavity or fallopian tube cancer or metastatic breast cancer Drugs used in chemotherapy such as ixabepilone and pegylated liposomal doxorubicin hydrochloride work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose and recommended phase II dose of ixabepilone when combined with pegylated doxorubicin hydrochloride HCl liposome pegylated liposomal doxorubicin hydrochloride in women with previously treated advanced ovarian epithelial primary peritoneal cavity or fallopian tube cancer or metastatic breast cancer
II To determine the safety profile of this regimen in these patients III To determine the clinical efficacy of this regimen in patients with platinum- and taxane-resistant advanced ovarian epithelial primary peritoneal cavity or fallopian tube cancer
OUTLINE This is a phase I multicenter open-label dose-escalation study of ixabepilone followed by a phase II study
Patients receive ixabepilone intravenously IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 Courses repeat every 21-28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for up to 2 years
I To determine the maximum tolerated dose and recommended phase II dose of ixabepilone when combined with pegylated doxorubicin hydrochloride HCl liposome pegylated liposomal doxorubicin hydrochloride in women with previously treated advanced ovarian epithelial primary peritoneal cavity or fallopian tube cancer or metastatic breast cancer
II To determine the safety profile of this regimen in these patients III To determine the clinical efficacy of this regimen in patients with platinum- and taxane-resistant advanced ovarian epithelial primary peritoneal cavity or fallopian tube cancer
OUTLINE This is a phase I multicenter open-label dose-escalation study of ixabepilone followed by a phase II study
Patients receive ixabepilone intravenously IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 Courses repeat every 21-28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for up to 2 years
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| P30CA013330 | NIH | CTEP | httpsreporternihgovquickSearchP30CA013330 |
| NCI-2009-00140 | OTHER | None | None |
| 0504007857 | OTHER | None | None |
| 7229 | OTHER | None | None |
| N01CM62204 | NIH | None | None |