Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: oxaliplatin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial cancer Stage III or IV disease Metastatic peritoneal, lymphatic, or visceral disease Measurable or evaluable disease Previously untreated disease OR relapsed disease more than 6 months after the completion of a platinum-containing chemotherapy regimen No symptomatic brain metastases PATIENT CHARACTERISTICS: Age 18 to 75 Performance status WHO 0-2 (0 in patients 70 to 75 years of age) Life expectancy Not specified Hematopoietic Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 1.25 times upper limit of normal (ULN) AST and ALT no greater than 3 times ULN Alkaline phosphatase less than 2.5 times ULN Renal Creatinine no greater than 1.4 mg/dL Other No serious uncontrolled infection No intolerance to polysorbate 80 No peripheral neuropathy greater than grade 1 No neurological or mental disease that would preclude study participation No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy See Disease Characteristics More than 4 weeks since prior chemotherapy No more than 1 prior chemotherapy regimen No prior oxaliplatin or docetaxel Endocrine therapy Not specified Radiotherapy More than 4 weeks since prior radiotherapy Surgery Not specified Other More than 28 days since prior participation in another clinical study No other concurrent anticancer treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Drug: oxaliplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose of docetaxel and oxaliplatin |  |  | 
| Toxicity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerance profile |  |  | 
| Recommended phase III dose |  |  | 
| Efficacy |  |  | 
| Complete pathological response |  |  | 
| Duration of the objective response |  |  | 
| Time to progression |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent ovarian epithelial cancer, stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer