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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GERCOR - Multidisciplinary Oncology Cooperative Group; Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
• Treatments: Docetaxel; Oxaliplatin

Criteria

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