Phase II Study of Oxaliplatin and 5 Fluorouracil in the Treatment of Advanced Ovarian Cancer
OBJECTIVES: I. Determine the efficacy of oxaliplatin in combination with fluorouracil in
terms of response rate, time to tumor progression, and overall survival in patients with
recurrent ovarian cancer. II. Evaluate the safety profile of this combination regimen in
this patient population.
OUTLINE: This is an open label study. Patients receive oxaliplatin IV over 2 hours once
every 2 weeks and fluorouracil IV and leucovorin calcium IV once weekly. Treatment repeats
every 2 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Patients with stable or responding disease are followed at 1 month and at 3 months, then
every 3 months for disease relapse and survival.
PROJECTED ACCRUAL: A total of 14-50 patients will be accrued for this study within 2 years.
Primary Purpose: Treatment
Kenneth O'Byrne, MD
University Hospitals, Leicester
United States: Federal Government