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

GERCOR - Multidisciplinary Oncology Cooperative Group

Status and phase

Unknown

Phase 2

Phase 1

Conditions

Ovarian Cancer

Treatments

Drug: docetaxel

Drug: oxaliplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT00075543

FRE-GERCOR-DOCELOX/O-01-1

EU-20332

CDR0000346887

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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