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)
Inclusion Criteria:
- 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 :
1. Hematology:
- 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
institution.
3. Renal function:
- Creatinine ≤1.5 times the upper normal limit (i.e., NCI grade ≤1)
- No severe or uncontrolled disease
Exclusion Criteria
- 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.