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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Prostatic Neoplasms

Treatments

Drug: docetaxel

Study type

Interventional

Funder types

Other

Industry

Identifiers

XRP6976J_2503

Details and patient eligibility

About

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®.

Sex

Male

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.