Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
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
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in
different ways to stop the growth of cancer cells, either by killing the cells or by
stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill
more cancer cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with
oxaliplatin works in treating patients with metastatic cancer who cannot receive
anthracycline or taxane therapy.
OBJECTIVES:
Primary
- Determine the objective response rate in patients with metastatic cancer not amenable
to anthracycline or taxane therapy treated with gemcitabine hydrochloride and
oxaliplatin.
Secondary
- Determine the clinical benefit and tolerability of this regimen in these patients.
- Determine the progression-free and overall survival of patients treated with this
regimen.
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
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