Taxotere Prostate Cancer New Indication Registration Trial in China

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.