A Phase II Trial of Weekly, Low-Dose Docetaxel (Taxotere) in Patients With Platinum-Resistant Epithelial Ovarian or Primary Peritoneal Serous Cancer
docetaxel
Maladies génito-urinaires+16
+ Maladies Génitales
+ Maladies Annexielles
Étude thérapeutique
Résumé
Date de début de l'étude : 1 juillet 1999
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the activity of docetaxel in women with platinum resistant, refractory ovarian epithelial or primary peritoneal serous cancer. OUTLINE: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive a minimum of 6 courses of therapy, including 2 courses beyond CR. PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 2 years.
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.30 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.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.À partir de 18 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 or primary peritoneal serous cancer that is resistant to platinum therapy Platinum resistance as defined by one of the following: Relapse within 6 months of platinum based chemotherapy Residual disease after completion of platinum based chemotherapy Disease progression while receiving platinum based chemotherapy Marker only relapse (CA-125 elevation) and measurable disease Bidimensionally measurable disease on exam or CT scan PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Performance status: ECOG 0-2 Life expectancy: Greater than 2 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGPT or SGOT no greater than 1.5 times ULN Alkaline phosphatase no greater than 2.5 times ULN Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: Acceptable cardiac exam No active cardiac ischemia Pulmonary: Acceptable pulmonary exam No active pulmonary infection or compromise Other: Not pregnant or nursing No severe peripheral neuropathy (grade 2 or greater) No other significant psychiatric or medical conditions that would interfere with compliance No other malignancies within the past 3 years, except: Limited basal or squamous cell skin cancer Carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: No prior cytokine therapy Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy for ovarian epithelial or peritoneal serous cancer Prior paclitaxel allowed No prior docetaxel At least 3 years since prior chemotherapy for other disease Endocrine therapy: Not specified Radiotherapy: No prior pelvic radiotherapy Surgery: Not specified
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 1 site
Beth Israel Deaconess Medical Center
Boston, United StatesOuvrir Beth Israel Deaconess Medical Center dans Google Maps