Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005051
Status:
COMPLETED
Last Update Posted:
2012-11-09
First Post:
2000-04-06
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Ovarian Epithelial Cancer
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Phase II Study of First-Line Therapy of Ovarian Cancer With Sequential Regimens Cisplatin-Prolonged Oral Topotecan C-PORT Followed by PaclitaxelCarboplatin PC
Status:
COMPLETED
Status Verified Date:
2003-12
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 combination chemotherapy in treating patients who have advanced ovarian epithelial cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have advanced ovarian epithelial cancer
Detailed Description:
OBJECTIVES
Determine the toxicity and tolerance of sequential therapy with prolonged
Determine the response rate and time to progression in this patient
Determine the relative pharmacokinetics of IV and prolonged oral administration of topotecan in the same patients and compare the pharmacodynamics of topo-1 inhibition when given by IV or oral route
OUTLINE
Regimen A Patients receive cisplatin IV over 60-90 minutes on day 1 of each course Topotecan IV is administered continuously on days 1-14 of course 1 Oral topotecan is administered twice daily on days 1-14 for courses 2 3 and 4 Treatment repeats every 28 days for 4 courses
Regimen B After completion of regimen A patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for 4 courses
PROJECTED ACCRUAL A total of 30 patients 15 per arm will be accrued for this study
Determine the toxicity and tolerance of sequential therapy with prolonged
Determine the response rate and time to progression in this patient
Determine the relative pharmacokinetics of IV and prolonged oral administration of topotecan in the same patients and compare the pharmacodynamics of topo-1 inhibition when given by IV or oral route
OUTLINE
Regimen A Patients receive cisplatin IV over 60-90 minutes on day 1 of each course Topotecan IV is administered continuously on days 1-14 of course 1 Oral topotecan is administered twice daily on days 1-14 for courses 2 3 and 4 Treatment repeats every 28 days for 4 courses
Regimen B After completion of regimen A patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for 4 courses
PROJECTED ACCRUAL A total of 30 patients 15 per arm will be accrued for this study
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-G00-1720 | None | None | None |
| NYU-9913 | None | None | None |