Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003065
Status:
COMPLETED
Last Update Posted:
2014-01-06
First Post:
1999-11-01
Brief Title:
Topotecan and Paclitaxel in Treating Patients With Recurrent or Metastatic Cancer of the Cervix
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Investigation of Topotecan and Taxol in Patients With RecurrentMetastatic Cancer of the Cervix
Status:
COMPLETED
Status Verified Date:
2003-09
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:
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 topotecan and paclitaxel in treating patients who have recurrent or metastatic cancer of the cervix
PURPOSE Phase II trial to study the effectiveness of topotecan and paclitaxel in treating patients who have recurrent or metastatic cancer of the cervix
Detailed Description:
OBJECTIVES
Determine the response time to progression disease free survival and overall survival of patients with recurrent andor metastatic cancer of the cervix treated with a combination of topotecan and paclitaxel
Determine the feasibility and toxicity of this regimen in these patients
OUTLINE Patients receive paclitaxel IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5 Filgrastim G-CSF is administered on days 6-14 Treatment repeats every 21 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 weeks
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 2 years
Determine the response time to progression disease free survival and overall survival of patients with recurrent andor metastatic cancer of the cervix treated with a combination of topotecan and paclitaxel
Determine the feasibility and toxicity of this regimen in these patients
OUTLINE Patients receive paclitaxel IV over 3 hours on day 1 and topotecan IV over 30 minutes on days 1-5 Filgrastim G-CSF is administered on days 6-14 Treatment repeats every 21 days for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 weeks
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 2 years
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 IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-V97-1324 | None | None | None |
| CPMC-IRB-7919 | None | None | None |