- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00084565
Paclitaxel, Topotecan, and Estramustine in Treating Patients With Metastatic Hormone-Refractory Prostate Cancer
Phase II Study of the Activity of Weekly Paclitaxel, Topotecan Plus Oral Estramustine Phosphate in Metastatic Hormone-Refractory Prostate Carcinoma
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, topotecan, and estramustine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving paclitaxel, topotecan, and estramustine together works in treating patients with metastatic hormone therapy-refractory prostate cancer.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Phase
- Phase 2
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Masquage: Aucun (étiquette ouverte)
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Gary R. Hudes, MD, Fox Chase Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs génitales, homme
- Maladies de la prostate
- Tumeurs prostatiques
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents antinéoplasiques, hormonaux
- Agents antinéoplasiques, alkylants
- Agents d'alkylation
- Agents antinéoplasiques phytogéniques
- Inhibiteurs de la topoisomérase
- Inhibiteurs de la topoisomérase I
- Paclitaxel
- Topotécan
- Estramustine
Autres numéros d'identification d'étude
- FCCC-03035
- CDR0000365459 (Identificateur de registre: PDQ (Physician Data Query))
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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