PHASE I STUDY OF PACLITAXEL COMBINED WITH TOPOTECAN AND CISPLATIN AND G-CSF IN PATIENTS WITH NEWLY DIAGNOSED ADVANCED OVARIAN EPITHELIAL MALIGNANCIES
paclitaxel
+ cisplatin
+ topotecan hydrochloride
Enfermedades Urogenitales+17
+ Enfermedades Genitales
+ Enfermedades Anexiales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de diciembre de 1996
Fecha en la que se inscribió al primer participante.PRIMARY OBJECTIVES: I. Determine the maximum tolerated doses of paclitaxel, cisplatin, and topotecan administered together with or without filgrastim (G-CSF) in patients with newly diagnosed advanced ovarian cancer. II. Describe and quantitate the clinical toxic effects of combination chemotherapy with paclitaxel, cisplatin, and topotecan with or without G-CSF. III. Assess preliminary evidence of antitumor activity of this combination chemotherapy in these patients. OUTLINE: This is a dose escalation study of topotecan. Patients receive paclitaxel IV over 3 hours and cisplatin IV on day 1, followed by topotecan IV over 30 minutes on days 1-3. Patients receive filgrastim (G-CSF) subcutaneously beginning on day 4 and continuing until blood counts recover. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 4-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities. Patients are followed as clinically indicated.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 30 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Histologically confirmed epithelial ovarian carcinoma No borderline ovarian carcinoma Stage III/IV disease that has been suboptimally or optimally debulked The following histologies are eligible: Adenocarcinoma (unspecified) Mucinous cystadenocarcinoma Clear cell adenocarcinoma Serous cystadenocarcinoma Endometrioid adenocarcinoma Transitional cell carcinoma Malignant Brenner's tumor Undifferentiated carcinoma Mixed epithelial carcinoma Extraovarian papillary serous cystadenocarcinoma Measurable or evaluable disease Performance status - GOG 0-1 Enabling completion of at least 2 courses of therapy Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Bilirubin no greater than 1.5 mg/dL Creatinine clearance at least 60 mL/min No myocardial infarction within 6 months No congestive heart failure No unstable or uncontrolled angina No history of cardiac arrhythmia requiring anti-arrhythmia medication No uncontrolled hypertension No hypersensitivity to E. coli-derived drug preparation No active infection No sensory neuropathy No other malignancies within the past 5 years except nonmelanomatous skin cancer No prior chemotherapy No prior radiotherapy Recovered from any recent surgery
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Un solo grupo de intervención está designado en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Gynecologic Oncology Group of Arizona
Phoenix, United StatesAbrir Gynecologic Oncology Group of Arizona en Google Maps