Ovarian Cancer Clinical Trial
Official title:
Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel and oxaliplatin, work in different
ways to stop tumor cells from dividing so they stop growing or die. Giving more than one
drug may kill more tumor cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of docetaxel and
oxaliplatin and to see how well they work in treating patients with stage III or stage IV
ovarian epithelial cancer.
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of docetaxel and oxaliplatin in patients with
stage III or IV ovarian epithelial cancer.
- Determine the toxicity of this regimen in these patients.
Secondary
- Determine the tolerance profile of patients treated with this regimen.
- Determine a recommended phase III dose of this regimen in these patients.
- Determine the efficacy of this regimen, in terms of objective response rate and
radiological and biological response rate (CA 125), in these patients.
- Determine the complete pathological response in patients treated with this regimen as
first-line therapy.
- Determine the duration of the objective response in patients treated with this regimen.
- Determine the time to progression in patients treated with this regimen.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive docetaxel IV over 1 hour and oxaliplatin IV over 2 hours on day 1.
Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or
unacceptable toxicity.
Patients are followed monthly for 3 months.
PROJECTED ACCRUAL: A total of 30-39 patients will be accrued for this study.
;
Primary Purpose: Treatment
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