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

NCT ID: NCT00268710

Last Updated: 2009-12-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-02-29
• Study Completion Date: 2006-03-31

Brief 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®.

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

docetaxel

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Urologic Oncology Group

OTHER

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Monique Furlan

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

XRP6976J_2503

Identifier Type: -

Identifier Source: org_study_id