A Phase II Study of Sequential Carboplatin, Paclitaxel and Hycamtin in Patients With Previously Untreated Advanced Ovarian Cancer
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.
Interventional
Primary Purpose: Treatment
Gordon J.S. Rustin, MD
Study Chair
Mount Vernon Cancer Centre at Mount Vernon Hospital
United States: Federal Government
CDR0000066848
NCT00003733
December 1997
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