Prostatic Neoplasms
Conditions
Brief summary
To compare overall survival after receiving mitoxantrone and prednisone or docetaxel and prednisone in subjects with hormone-refractory metastatic prostate cancer.
Interventions
DRUGDocetaxel
75mg/m² intravenously (day 1) every 21 days
DRUGMitoxantrone
12mg/m² intravenously every 21 days
DRUGPrednisone
10mg orally given daily
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically proven prostate adenocarcinoma * Androgen independent prostate Cancer S/P orchiectomy and/or LHRH agonist Testosterone \< 50 ng/dl (ie 1.735 nmol/l) * Documented progressive disease * Patients should have achieved stable analgesia for 7 days * Karnofsky Performance Status ≥ 70 * No prior treatment with cytotoxic agent (except estramustine) * Normal cardiac function must be confirmed by Left ventricular ejection fraction * Adequate organ function: 1. Hematology: * Neutrophils \> 1.5 x 10\^9/L * Hemoglobin \> 10 g/dl. Erythropoietin use is allowed, but red blood cell transfusion to upgrade the hemoglobin level is not allowed * Platelets \> 100 x 10\^9/L 2. Hepatic function: * Total bilirubin \< the upper-normal limit of the institution. * Alanine aminotransferase and Aspartate transaminase \< 1.5 times the upper-normal limit of the institution. 3. Renal function: * Creatinine \< 1.5 times the upper normal limit (ie National Cancer Institution grade \< 1) * No brain or leptomeningeal metastases
Exclusion criteria
* Prior radiotherapy to \>25% of bone marrow (whole pelvic irradiation is not allowed) * prior cytotoxic chemotherapy, except monotherapy with estramustine * prior isotope therapy * history of another cancer within the preceding five year * symptomatic peripheral neuropathy grade ≥ 2 * other serious illness or medical condition: 1. Congestive heart failure even if controlled. Previous history of myocardial infarction or angina pectoris within 1 year from study entry, uncontrolled hypertension or uncontrolled arrhythmias. 2. Active uncontrolled infection 3. Peptic ulcer, unstable diabetes mellitus or other contraindications for the use of corticosteroids. 4. Auto-immune disease (lupus, sclerodermia, rheumatoid polyarthritis) * treatment with any other anti-cancer therapy * treatment with bisphosphonates The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prostatic Specific Antigen response | From the beginning to the end of study |
| Pain response (McGill-Melzack Scale) | From beginning to end of study |
| Time to progression | From beginning to end of study |
| Adverse event | From beginning to end of study |
| Efficacy: Overall survival | From beginning to end of the study |
| Objective response rate of patients with measurable disease by Response Evaluation Criteria in Solid tumours | From beginning to end of study |
| Quality Of Life: Functional assessment of chronic illness therapy-prostate questionnaire will be used | From beginning to end of study |
Countries
China
Outcome results
None listed