Status:
UNKNOWN
Docetaxel and Oxaliplatin in Treating Patients With Stage III or Stage IV Ovarian Epithelial Cancer
Lead Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00075543
Start Date
July 1 2003
Last Update
July 24 2008
Active Locations (5)
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1
Intercommunal Hospital
Montfermeil, France, 93370
2
Hopital Saint Antoine
Paris, France, 75012
3
Hopital Tenon
Paris, France, 75970
4
Polyclinique De Courlancy
Reims, France, F-51100