Phase II Study of the Activity of Weekly Paclitaxel, Topotecan Plus Oral Estramustine Phosphate in Metastatic Hormone-Refractory Prostate Carcinoma
Collecte de données
Maladies génito-urinaires+7
+ Maladies Génitales
+ Maladies génitales masculines
Étude thérapeutique
Résumé
Date de début de l'étude : 1 novembre 2003
Date à laquelle le premier participant a commencé l'étude.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.
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.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.Homme
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 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