PHASE I/II TRIAL OF TAXOL, IFOSFAMIDE, AND CISPLATIN FOR CISPLATIN-RESISTANT GERM CELL TUMOR PATIENTS WITH FAVORABLE PROGNOSTIC FEATURES
filgrastim
+ cisplatin
+ ifosfamide
Enfermedades Urogenitales+15
+ Enfermedades Genitales
+ Enfermedades Anexiales
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de enero de 1994
Fecha en la que se inscribió al primer participante.OBJECTIVES: Determine the toxicity and optimal dose of paclitaxel when combined with cisplatin and ifosfamide in patients with germ cell tumors with favorable prognostic features and resistance to cisplatin. Determine the efficacy of this regimen as salvage therapy in these patients. OUTLINE: This is a dose escalation study of paclitaxel. Patients receive paclitaxel IV continuously on day 1 and cisplatin IV over 20 minutes and ifosfamide IV over 30 minutes on days 2-6. Filgrastim (G-CSF) is administered subcutaneously (SC) on days 7-18 or until blood counts recover. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose-limiting toxicity. Additional patients receive paclitaxel at the MTD. After completion of chemotherapy, some patients may undergo resection of residual masses. PROJECTED ACCRUAL: A total of 18-43 patients will be accrued for this study within 2 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 43 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.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.A partir de 15 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
DISEASE CHARACTERISTICS: Histologically proven germ cell tumor that is resistant to a platinum-based chemotherapy regimen Active disease meeting 1 of the following conditions: Measurable or evaluable disease Elevated serum tumor markers (alpha-fetoprotein or human chorionic gonadotropin) Unresectable residual disease after postchemotherapy surgery Favorable prognostic factors for achieving a complete response (CR) to cisplatin-based salvage therapy required, including all of the following: No more than 1 prior regimen or 6 prior courses of cisplatin Testis or ovarian germ cell primary site Prior CR to cisplatin therapy Incomplete response to first-line therapy that was based on either carboplatin or a suboptimal regimen of cisplatin PATIENT CHARACTERISTICS: Age: 15 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 8.0 g/dL Hepatic: Not specified Renal: Creatinine clearance greater than 50 mL/min Renal dysfunction due to ureteral obstruction by tumor allowed at the discretion of the principal investigator Cardiovascular: If history of significant cardiac disease, evaluation and clearance by a cardiologist required prior to entry Other: No active infection not well controlled on antibiotics PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No prior paclitaxel or ifosfamide At least 3 weeks since prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics Recovered from recent surgery
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
Memorial Sloan-Kettering Cancer Center
New York, United StatesAbrir Memorial Sloan-Kettering Cancer Center en Google Maps