Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025155
Status:
COMPLETED
Last Update Posted:
2019-07-24
First Post:
2001-10-11
Brief Title:
Ixabepilone in Treating Patients With Ovarian Epithelial or Primary Peritoneal Cancer That Has Not Responded to Previous Chemotherapy
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Evaluation of Epothilone-B BMS 247550 NSC 710428 in the Treatment of Recurrent or Persistent Platinum and Paclitaxel Refractory Ovarian or Primary Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2019-07
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:
Phase II trial to study the effectiveness of ixabepilone in treating patients who have recurrent or persistent ovarian epithelial or primary peritoneal cancer that has not responded to previous chemotherapy Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I Determine the antitumor activity of ixabepilone in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer
II Determine the nature and degree of toxicity of this drug in these patients
OUTLINE
Patients receive ixabepilone IV over 1 hour Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive 2 additional courses after achieving CR
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
I Determine the antitumor activity of ixabepilone in patients with recurrent or persistent platinum and paclitaxel-refractory ovarian epithelial or primary peritoneal cancer
II Determine the nature and degree of toxicity of this drug in these patients
OUTLINE
Patients receive ixabepilone IV over 1 hour Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients with a complete response CR receive 2 additional courses after achieving CR
Patients are followed every 3 months for 2 years and then every 6 months for 3 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 |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2012-02413 | REGISTRY | None | None |
| CDR0000068927 | None | None | None |
| GOG-0126M | OTHER | None | None |
| GOG-0126M | OTHER | None | None |