Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
Recruitment status was: Active, not recruiting
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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer|
- Maximum tolerated dose of docetaxel and oxaliplatin [ Designated as safety issue: Yes ]
- Toxicity [ Designated as safety issue: Yes ]
- Tolerance profile [ Designated as safety issue: Yes ]
- Recommended phase III dose [ Designated as safety issue: No ]
- Efficacy [ Designated as safety issue: No ]
- Complete pathological response [ Designated as safety issue: No ]
- Duration of the objective response [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
|Study Start Date:||July 2003|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075543
|Montfermeil, France, 93370|
|Hopital Saint Antoine|
|Paris, France, 75012|
|Paris, France, 75970|
|Polyclinique De Courlancy|
|Reims, France, F-51100|
|Senlis, France, 60309|
|Study Chair:||Christophe Tournigand||Hopital Saint Antoine|