Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-31 @ 11:27 AM
Study NCT ID:
NCT00003733
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sequential Chemotherapy in Treating Patients With Residual Disease Following Surgery for Stage IIB, Stage III, or Stage IV Ovarian Cancer
Sponsor:
SmithKline Beecham
Organization:
Study Overview
Official Title:
A Phase II Study of Sequential Carboplatin, Paclitaxel and Hycamtin in Patients With Previously Untreated Advanced Ovarian Cancer
Status:
UNKNOWN
Status Verified Date:
2000-12
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. Giving chemotherapy drugs in different ways may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of sequential chemotherapy in treating patients with residual disease following surgery for stage IIB, stage III, or stage IV ovarian cancer.
PURPOSE: Phase II trial to study the effectiveness of sequential chemotherapy in treating patients with residual disease following surgery for stage IIB, stage III, or stage IV ovarian cancer.
Detailed Description:
OBJECTIVES: I. Evaluate the efficacy of sequential carboplatin, paclitaxel, and topotecan in terms of disease response, time to progression, survival and progression free survival in patients with stage IIB, stage III, or stage IV ovarian epithelial cancer. II. Assess the toxicity of this regimen in this patient population.
OUTLINE: Patients receive carboplatin IV over 30 to 60 minutes on days 1 and 22. Patients then receive paclitaxel IV over 3 hours on days 43 and 64, then topotecan IV over 30 minutes daily for 5 days beginning on days 85, 106, 127, and 148. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
OUTLINE: Patients receive carboplatin IV over 30 to 60 minutes on days 1 and 22. Patients then receive paclitaxel IV over 3 hours on days 43 and 64, then topotecan IV over 30 minutes daily for 5 days beginning on days 85, 106, 127, and 148. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months and then every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
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?: