Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer
18 Years
75 Years
Female
Ovarian Cancer
Trial Information
Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of docetaxel and oxaliplatin
Safety Issue:
Yes
Principal Investigator
Christophe Tournigand
Investigator Role:
Study Chair
Investigator Affiliation:
Hopital Saint Antoine
Authority:
United States: Federal Government
Study ID:
CDR0000346887
NCT ID:
NCT00075543
Start Date:
July 2003
Completion Date:
Related Keywords:
- Ovarian Cancer
- recurrent ovarian epithelial cancer
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial
Name | Location |
|---|
