Multicenter Phase II Study Evaluating Gemcitabine and Oxaliplatin in the Treatment of Patients Suffering From Metastatic Breast Cancer Who Are Not Candidates For Treatment With Antracyclines and Taxanes
- Determine the objective response rate in patients with metastatic cancer not amenable
to anthracycline or taxane therapy treated with gemcitabine hydrochloride and
- Determine the clinical benefit and tolerability of this regimen in these patients.
- Determine the progression-free and overall survival of patients treated with this
OUTLINE: This is an open-label, multicenter study.
Patients receive gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV
over 2 hours on day 2. Treatment repeats every 2 weeks in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Objective response rate
Joseph Gligorov, MD
United States: Federal Government