Phase II Study of Weekly Paclitaxel and Gemcitabine in Platinum-Resistant Ovarian Cancer
dexamethasone
+ gemcitabine hydrochloride
+ paclitaxel
Maladies génito-urinaires+16
+ Maladies Génitales
+ Maladies Annexielles
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mai 1998
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Determine the response rate, progression time, and survival of patients with platinum-resistant ovarian cancer treated with weekly paclitaxel and gemcitabine. Determine the toxic effects of this regimen in these patients. Evaluate the toxic effects and safety profile of premedication with steroids with this regimen in these patients. OUTLINE: Patients are stratified according to prior treatment with paclitaxel (none or relapse more than 6 months after paclitaxel versus progressive disease or relapse less than 6 months after paclitaxel). Patients receive dexamethasone IV, then paclitaxel IV followed by gemcitabine IV, for 3 consecutive weeks on days 1, 8, and 15. Treatment is continued every 4 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed until death. PROJECTED ACCRUAL: Approximately 18-35 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.35 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 recurrent ovarian epithelial cancer Platinum resistant disease defined as: Progression during the most recent platinum-based chemotherapy OR Relapse less than 6 months after platinum-based chemotherapy Measurable or evaluable disease Elevated CA-125 only allowed Positive cytology only not eligible PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Hematopoietic: Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) AST less than 3 times ULN Renal: Creatinine no greater than 2 mg/dL Neurologic: No peripheral neuropathy greater than grade 2 Other: No other serious medical illness or psychiatric conditions. PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent hematopoietic growth factors Chemotherapy: See Disease Characteristics No prior gemcitabine No prior paclitaxel administered weekly Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: Recovered from acute toxic effects secondary to prior therapy
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
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, United StatesOuvrir USC/Norris Comprehensive Cancer Center and Hospital dans Google Maps