Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00313612
Status:
TERMINATED
Last Update Posted:
2015-11-27
First Post:
2006-04-11
Brief Title:
Oxaliplatin and Topotecan in Advance Ovarian Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Oxaliplatin Combined With Continuous Infusion Topotecan as Chemotherapy for Patients With Previously Treated Ovarian Cancer
Status:
TERMINATED
Status Verified Date:
2013-05
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 giving oxaliplatin together with topotecan works in treating patients with ovarian epithelial cancer primary peritoneal cancer or fallopian tube cancer Drugs used in chemotherapy such as oxaliplatin and topotecan 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 Estimate the overall clinical response rate complete and partial responses in patients with previously treated ovarian epithelial primary peritoneal or fallopian tube cancer treated with oxaliplatin and topotecan
II Determine the toxic effects in patients treated with this regimen
SECONDARY OBJECTIVES
I Estimate the time to progression and overall clinical response duration in patients treated with this regimen
OUTLINE This is an open-label multicenter study Patients are stratified according to response to prior platinum therapy resistant vs sensitive
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 30 days
I Estimate the overall clinical response rate complete and partial responses in patients with previously treated ovarian epithelial primary peritoneal or fallopian tube cancer treated with oxaliplatin and topotecan
II Determine the toxic effects in patients treated with this regimen
SECONDARY OBJECTIVES
I Estimate the time to progression and overall clinical response duration in patients treated with this regimen
OUTLINE This is an open-label multicenter study Patients are stratified according to response to prior platinum therapy resistant vs sensitive
Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed at 30 days
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 |
|---|---|---|---|
| N01CM62204 | NIH | New York University | httpsreporternihgovquickSearchN01CM62204 |
| NYU 03-67 | OTHER | None | None |