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

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)

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®.

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: docetaxel

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain (pain progression evaluated with the Present Pain Intensity scale form McGill-Melzack questionnaire)	During the Study Conduct

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	During the study conduct
Analgesics (assessed by Pain Medication Log)	During the study conduct
PSA (PSA response and PSA progression	During the study conduct
Tumor lesion assessment,	During the study conduct
Progression-free survival	During the study conduct
Treatment emergent adverse events recorded by the investigator where intensity was according to NCI-CTC criteria: Standard hematology, blood chemistry and clinical exams.	from the inform consent signed up to the end of the study

Collaborators and Investigators

• Sponsor: Sanofi
• Collaborators: Canadian Urologic Oncology Group
• Investigators: Study Director: Monique Furlan, Sanofi

Study record dates

Study Major Dates

• Study Start: February 1, 2004
• Primary Completion (Actual): March 1, 2006
• Study Completion (Actual): March 1, 2006

Study Registration Dates

• First Submitted: December 21, 2005
• First Submitted That Met QC Criteria: December 21, 2005
• First Posted (Estimate): December 22, 2005

Study Record Updates

• Last Update Posted (Estimate): December 7, 2009
• Last Update Submitted That Met QC Criteria: December 4, 2009
• Last Verified: December 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: XRP6976J_2503