NCT00003733

Sequential Chemotherapy in Treating Patients With Residual Disease Following Surgery for Stage IIB, Stage III, or Stage IV Ovarian Cancer

A Phase II Study of Sequential Carboplatin, Paclitaxel and Hycamtin in Patients With Previously Untreated Advanced Ovarian Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: SmithKline Beecham · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	carboplatin
DRUG	paclitaxel
DRUG	topotecan hydrochloride

Timeline

• Start date: 1997-12-01
• First posted: 2004-06-09
• Last updated: 2013-09-20

Locations

2 sites across 1 country: United Kingdom