Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003732
Status:
COMPLETED
Last Update Posted:
2013-08-12
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Stage II Stage III or Stage IV Ovarian Cancer
Sponsor:
Rigshospitalet Denmark
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study to Determine the Maximum Tolerated Doses of Oral Topotecan Carboplatin and Paclitaxel Administered Every 21 Days to Patients With Epithelial Ovarian Cancer Stages IIb IIc III and IV
Status:
COMPLETED
Status Verified Date:
2002-07
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 cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase III trial to study the effectiveness of topotecan combined with carboplatin and paclitaxel in treating patients who have stage II stage III or stage IV ovarian cancer
PURPOSE Phase III trial to study the effectiveness of topotecan combined with carboplatin and paclitaxel in treating patients who have stage II stage III or stage IV ovarian cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose dose-limiting toxicity and quantitative and qualitative toxic effects of oral topotecan combined with intravenous carboplatin and paclitaxel in patients with stage IIB IIC III or IV ovarian epithelial cancer phase I closed to accrual 122100
Evaluate the anti-tumor activity of this regimen in this patient population
OUTLINE This is a multicenter dose-escalation study of topotecan
Patients receive oral topotecan on days 1-5 and paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 5 Courses repeat every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Phase I Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity phase I closed to accrual 122100
Phase II An additional 50 patients receive up to 6 courses of treatment as in phase I at the MTD
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 80 patients 30 in phase I and 50 in phase II will be accrued for this study phase I closed to accrual 122100
Determine the maximum tolerated dose dose-limiting toxicity and quantitative and qualitative toxic effects of oral topotecan combined with intravenous carboplatin and paclitaxel in patients with stage IIB IIC III or IV ovarian epithelial cancer phase I closed to accrual 122100
Evaluate the anti-tumor activity of this regimen in this patient population
OUTLINE This is a multicenter dose-escalation study of topotecan
Patients receive oral topotecan on days 1-5 and paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 5 Courses repeat every 21 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity
Phase I Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity phase I closed to accrual 122100
Phase II An additional 50 patients receive up to 6 courses of treatment as in phase I at the MTD
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 80 patients 30 in phase I and 50 in phase II will be accrued for this study phase I closed to accrual 122100
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 |
|---|---|---|---|
| SB-104864373 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066847 | REGISTRY | None | None |
| DAN-104864-A373 | None | None | None |
| EU-98052 | None | None | None |
| SB-104864-A373 | None | None | None |