Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334893
Status:
COMPLETED
Last Update Posted:
2017-11-29
First Post:
2006-06-07
Brief Title:
Eribulin Mesylate in Treating Patients With Recurrent Ovarian Epithelial Primary Peritoneal Cavity or Fallopian Tube Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
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:
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 |
|---|---|---|---|
| NCI-2009-00169 | REGISTRY | None | None |
| MSKCC-06027 | None | None | None |
| NCI-7431 | None | None | None |
| CDR0000481534 | None | None | None |
| 06-027 | OTHER | None | None |
| 7431 | OTHER | None | None |
| P30CA008748 | NIH | None | None |
| N01CM62206 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62206 |