A Randomized Phase III Trial of Paclitaxel, Carboplatin and Etoposide Vs. 5-Fluorouracil and Folinic Acid in the Treatment of Patients With Adenocarcinoma of Unknown Primary Site
carboplatin
+ etoposide
+ fluorouracil
Metástasis Neoplásica+3
+ Neoplasias
+ Procesos Neoplásicos
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de agosto de 1998
Fecha en la que se inscribió al primer participante.OBJECTIVES: Compare the overall survival after treatment with paclitaxel, carboplatin, and etoposide and after treatment with fluorouracil and leucovorin calcium in patients with adenocarcinoma of unknown primary. Compare the response rates, progression free survival, toxicity profile, and quality of life between the two regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center and presence or absence of liver metastases. Patients are randomly assigned to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1, and oral etoposide on days 1-10. Treatment is repeated every 3 weeks for up to four courses. Arm II: Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV over 24 hours weekly for 6 weeks. Treatment is repeated every 7 weeks for up to two courses. Patients are followed every 3 months after treatment for 1 year or until death. Quality of life questionnaires are completed at each follow-up. PROJECTED ACCRUAL: Approximately 120-140 patients will be accrued for this study within 3 years.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 140 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 18 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 confirmed adenocarcinoma of any differentiation grade Excludes the following "treatable" conditions: Axillary node involvement Peritonitis carcinomatosis Blastic bone metastases and/or elevated PSA Squamous cell cancer with cervical or inguinal presentation Poorly differentiated carcinoma Neuroendocrine tumors OR Tumors located in the mediastinum, retroperitoneum, or nodes At least one measurable metastatic site No brain or meningeal metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: ECOG 0-2 Hematopoietic: Leukocyte count at least 4,000/mm3 Thrombocyte count at least 100,000/mm3 Hepatic: Bilirubin less than 1.4 mg/dL AST and ALT less than 3 times upper limit of normal No cirrhosis of the liver Renal: Creatinine less than 1.7 mg/dL Cardiovascular: At least 3 months since myocardial infarction No congestive heart failure, tachydysrhythmia, or unstable angina pectoris Other: Not pregnant or nursing Negative pregnancy test No active infection No other serious illness or medical condition No current or prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy (no greater than 25% of bone marrow) Surgery: Not specified
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 2 ubicaciones
Academisch Ziekenhuis Maastricht
Maastricht, NetherlandsAbrir Academisch Ziekenhuis Maastricht en Google MapsSt. Elisabeth Ziekenhuis
Tilburg, Netherlands