Docetaxel in Hormone Refractory Prostate Cancer (HRPC)[Weekly or 3weekly TAX + Prednisone in HRPC]

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: Male

Summary

Primary objectives:

• To determine the response rate, measurable and non measurable, to Taxotere® in the second line setting.

Secondary objectives:

• To evaluate the overall safety and toxicity of Taxotere®/prednisone combination as second line therapy in HRPC

• To evaluate PSA response (PSA: Prostate Specific Antigen)

• To evaluate symptomatic response

• To evaluate Quality of life

• To evaluate patient safety of weekly versus q3 weekly regimens of Taxotere®.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Canadian Urologic Oncology Group
• Treatments: Docetaxel; Hormones; Prednisone

Criteria

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.