Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT00334893
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2006-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial, Primary Peritoneal Cavity, or Fallopian Tube Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Multi-Center Phase II Study of the Halichondrin B Analog E7389 in Recurrent Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
Status:
COMPLETED
Status Verified Date:
2017-10
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 phase II trial is studying how well eribulin mesylate works in treating patients with recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
Detailed Description:
PRIMARY OBJECTIVES:
I. Determine the frequency of objective response (complete and partial responses) in patients with recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer treated with E7389 (eribulin mesylate).
SECONDARY OBJECTIVES:
II. Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior platinum sensitivity (yes vs no).
Patients receive eribulin mesylate intravenously (IV) over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
I. Determine the frequency of objective response (complete and partial responses) in patients with recurrent ovarian epithelial, primary peritoneal cavity, or fallopian tube cancer treated with E7389 (eribulin mesylate).
SECONDARY OBJECTIVES:
II. Determine the toxicity profile of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior platinum sensitivity (yes vs no).
Patients receive eribulin mesylate intravenously (IV) over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for 4 weeks.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2009-00169 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| MSKCC-06027 | None | None | View | |
| NCI-7431 | None | None | View | |
| CDR0000481534 | None | None | View | |
| 06-027 | OTHER | Memorial Sloan-Kettering Cancer Center | View | |
| 7431 | OTHER | CTEP | View | |
| P30CA008748 | NIH | None | https://reporter.nih.gov/quic… | View |
| N01CM62206 | NIH | None | https://reporter.nih.gov/quic… | View |