Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer
Data Collection
Carcinoma, Ovarian Epithelial+16
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
Summary
Study start date: July 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 5 locations
Hopital Saint Antoine
Paris, FranceHopital Tenon
Paris, FrancePolyclinique De Courlancy
Reims, France