Multicenter Phase II Study of Taxotere (Docetaxel) Administered Weekly or Every Three Weeks in Combination With Prednisone as Second Line Chemotherapy in Patients With Hormone Refractory Prostate Cancer (HRPC)
- Histologically/cytologically proven prostate adenocarcinoma
- Progression or non response with previous chemotherapy regimen (excluding Taxotere®)
- Received previous mitoxantrone/prednisone or one other chemotherapy regimen including
emcyt +/- vinblastine
- Castration levels of testosterone (<50 ng/dL )
- ECOG performance status 0-2
- Laboratory requirements :
- Neutrophils ≥ 1.5 x 10^9/L
- Hemoglobin > 10 g/dL (prior transfusion permitted).
- Platelets ≥ 100 x 10^9/L
2. Hepatic function:
- Total bilirubin < the upper-normal limit of the institution.
- ALAT (SGPT) and ASAT (SGOT) ≤ 1.5 times the upper-normal limit of the
3. Renal function:
- Creatinine ≤1.5 times the upper normal limit (i.e., NCI grade ≤1)
- No severe or uncontrolled disease
- Chemotherapy within the last 4 weeks
- Anti-androgen therapy within the last 4 weeks.
- Prior malignancy except the following: adequately treated non-melanomatous skin
cancer and superficial bladder cancer from which the patient has been disease-free
for >2 years.
- Concurrent treatment with other experimental drugs. Participation in another clinical
trial with any investigational drug within 30 days prior to study screening.
- Treatment with any other anti-cancer therapy (except LHRH agonists) including any
prescribed compounds and/or OTC products for the treatment of prostate cancer must be
stopped prior to study entry.
- Other serious illness, psychiatric or medical condition that would not permit the
patient to be managed according to the protocol including active uncontrolled
infection and significant cardiac dysfunction.