Phase II Study of the Activity of Weekly Paclitaxel, Topotecan Plus Oral Estramustine Phosphate in Metastatic Hormone-Refractory Prostate Carcinoma
Colección de datos
Enfermedades Urogenitales+6
+ Enfermedades Genitales
+ Enfermedades Genitales Masculinas
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de noviembre de 2003
Fecha en la que se inscribió al primer participante.OBJECTIVES: Primary * Determine the objective response rate in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel, topotecan, and estramustine. * Determine the progression-free and overall survival of patients treated with this regimen. * Determine the toxic effects of this regimen in these patients. * Determine the pharmacokinetics of this regimen in these patients. Secondary * Determine the frequency and number of circulating tumor cells in patients before and after treatment with this regimen and at disease progression. * Determine the microtubule morphology, β-tubulin isotype pattern, apoptotic markers, and metaphase chromosome alignment in circulating tumor cells in patients before and after treatment with this regimen and at disease progression. OUTLINE: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15; topotecan IV over 30 minutes on days 2, 9, and 16; and oral estramustine twice daily on days 1 and 2 of course 1 and on days 0-2, 7-9, and 14-16 of all subsequent courses. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 18-38 patients will be accrued for this study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Hombre
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 the prostate gland * Progressive metastatic disease (e.g., bone, pelvic mass, lymph node, liver or lung metastases) * Radiologic evidence of hydronephrosis alone dose not constitute metastatic disease * Failed prior primary hormonal therapy (e.g., estrogen therapy, luteinizing hormone-releasing hormone blocker and flutamide) or bilateral orchiectomy * Patients previously treated with flutamide or bicalutamide must have evidence of disease progression i.e., increasing Prostate-Specific Antigen (PSA) * PSA level ≥ 10 ng/mL if bone metastases only are present (i.e., lacking measurable soft tissue disease) * No elevated serum acid phosphatase or PSA level as the only evidence of disease * No carcinomatous meningitis or brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Eastern Cooperative Oncology Group (ECOG) 0-2 Life expectancy * At least 12 weeks Hematopoietic * White Blood Cell (WBC) ≥ 4,000/mm\^3 OR * Granulocyte count ≥ 2,000/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Serum Glutamic-Oxaloacetic Transaminase(SGOT) and Serum Glutamic-Pyruvic Transaminase (SGPT) ≤ 2 times normal * Bilirubin ≤ 1.5 mg/dL Renal * Creatinine ≤ 2.0 mg/dL OR * Creatinine clearance ≥ 50 mL/min Cardiovascular * History of deep venous thrombosis allowed provided patients are maintained on therapeutic anticoagulation therapy * No active angina pectoris * No New York Heart Association class II-IV heart disease * No myocardial infarction within the past 6 months * No thrombosis within the past 3 months Other * Fertile patients must use effective contraception during and for 3 months after study participation * No active infection * No other concurrent serious medical illness that would preclude study participation * No other malignancy within the past 3 years except curatively treated basal cell or squamous cell skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * See Disease Characteristics * At least 4 weeks since prior flutamide * At least 8 weeks since prior bicalutamide Radiotherapy * More than 4 weeks since prior radiotherapy * No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium Surgery * See Disease Characteristics Other * Recovered from all prior therapy * No prior cytotoxic therapy for prostate cancer * No concurrent milk, milk products, antacids, calcium-containing drugs, or food during estramustine administration