Status:
COMPLETED
Taxotere Prostate Cancer New Indication Registration Trial in China
Lead Sponsor:
Sanofi
Conditions:
Prostatic Neoplasms
Eligibility:
MALE
Phase:
PHASE3
Brief Summary
To compare overall survival after receiving mitoxantrone and prednisone or docetaxel and prednisone in subjects with hormone-refractory metastatic prostate cancer.
Eligibility Criteria
Inclusion
- 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:
- 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
- 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.
- Renal function:
- Creatinine \< 1.5 times the upper normal limit (ie National Cancer Institution grade \< 1)
- No brain or leptomeningeal metastases
Exclusion
- 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:
- 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.
- Active uncontrolled infection
- Peptic ulcer, unstable diabetes mellitus or other contraindications for the use of corticosteroids.
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT00436839
Start Date
January 1 2007
End Date
June 1 2012
Last Update
July 9 2012
Active Locations (1)
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1
Sanofi-Aventis Administrative Office
Shanghai, China