Phase I-II Study Of Docetaxel And Oxaliplatine In Patients With Stage III-IV Ovarian Epithelial Cancer
Collecte de données
Carcinome épithélial ovarien+16
+ Maladies génito-urinaires
+ Maladies Génitales
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 2003
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 75 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 5 sites
Hopital Saint Antoine
Paris, FranceHopital Tenon
Paris, FrancePolyclinique De Courlancy
Reims, France