Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003733
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
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:
National Cancer Institute NCI
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:
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-98068 | None | None | None |
| SB-104864289 | None | None | None |