Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004206
Status:
UNKNOWN
Last Update Posted:
2014-06-24
First Post:
2000-01-21
Brief Title:
Oxaliplatin and Fluorouracil in Treating Patients With Recurrent Ovarian Cancer
Sponsor:
University of Leicester
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Oxaliplatin and 5 Fluorouracil in the Treatment of Advanced Ovarian Cancer
Status:
UNKNOWN
Status Verified Date:
2002-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining oxaliplatin and fluorouracil in treating patients who have recurrent ovarian cancer
PURPOSE Phase II trial to study the effectiveness of combining oxaliplatin and fluorouracil in treating patients who have recurrent ovarian cancer
Detailed Description:
OBJECTIVES I Determine the efficacy of oxaliplatin in combination with fluorouracil in terms of response rate time to tumor progression and overall survival in patients with recurrent ovarian cancer II Evaluate the safety profile of this combination regimen in this patient population
OUTLINE This is an open label study Patients receive oxaliplatin IV over 2 hours once every 2 weeks and fluorouracil IV and leucovorin calcium IV once weekly Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease are followed at 1 month and at 3 months then every 3 months for disease relapse and survival
PROJECTED ACCRUAL A total of 14-50 patients will be accrued for this study within 2 years
OUTLINE This is an open label study Patients receive oxaliplatin IV over 2 hours once every 2 weeks and fluorouracil IV and leucovorin calcium IV once weekly Treatment repeats every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease are followed at 1 month and at 3 months then every 3 months for disease relapse and survival
PROJECTED ACCRUAL A total of 14-50 patients will be accrued for this study within 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 |
|---|---|---|---|
| EU-99036 | None | None | None |
| LRI-IND02-V3 | None | None | None |