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

GERCOR - Multidisciplinary Oncology Cooperative Group

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Ovarian Cancer

Interventions

docetaxelDRUG

oxaliplatinDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (5)

Intercommunal Hospital

Montfermeil, France

Hopital Saint Antoine

Paris, France

Hopital Tenon

Paris, France

Polyclinique De Courlancy

Reims, France

C.H. Senlis

Senlis, France

Outcomes

Primary Outcomes

Maximum tolerated dose of docetaxel and oxaliplatin

Toxicity

Secondary Outcomes

Tolerance profile

Recommended phase III dose

Efficacy

Complete pathological response

Duration of the objective response

Time to progression

Data from ClinicalTrials.gov

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