This trial is active, not recruiting.

Condition ovarian cancer
Treatments docetaxel, oxaliplatin
Phase phase 1/phase 2
Sponsor Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Start date July 2003
Trial identifier NCT00075543, CDR0000346887, EU-20332, FRE-GERCOR-DOCELOX/O-01-1


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Primary purpose treatment

Primary Outcomes

Maximum tolerated dose of docetaxel and oxaliplatin
time frame:
time frame:

Secondary Outcomes

Tolerance profile
time frame:
Recommended phase III dose
time frame:
time frame:
Complete pathological response
time frame:
Duration of the objective response
time frame:
Time to progression
time frame:

Eligibility Criteria

Female participants from 18 years up to 75 years old.

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

Additional Information

Official title Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2008.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).