NCT00004206

Oxaliplatin and Fluorouracil in Treating Patients With Recurrent Ovarian Cancer

Phase II Study of Oxaliplatin and 5 Fluorouracil in the Treatment of Advanced Ovarian Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: University of Leicester · Academic / Other
• 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. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin and fluorouracil in treating patients who have recurrent ovarian cancer.

Detailed description

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.

Conditions

• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	FOLFOX regimen
DRUG	fluorouracil
DRUG	leucovorin calcium
DRUG	oxaliplatin

Timeline

• Start date: 1999-09-01
• First posted: 2003-11-04
• Last updated: 2014-06-24

Locations

1 site across 1 country: United Kingdom