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

This study has been completed.
Sponsor:
Collaborator:
Canadian Urologic Oncology Group
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00268710
First received: December 21, 2005
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

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®.

Condition Intervention Phase
Prostatic Neoplasms
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Pain (pain progression evaluated with the Present Pain Intensity scale form McGill-Melzack questionnaire) [ Time Frame: During the Study Conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Analgesics (assessed by Pain Medication Log) [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • PSA (PSA response and PSA progression [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Tumor lesion assessment, [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
  • Treatment emergent adverse events recorded by the investigator where intensity was according to NCI-CTC criteria: Standard hematology, blood chemistry and clinical exams. [ Time Frame: from the inform consent signed up to the end of the study ] [ Designated as safety issue: No ]

Study Start Date: February 2004
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268710

Sponsors and Collaborators
Sanofi
Canadian Urologic Oncology Group
Investigators
Study Director: Monique Furlan Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00268710     History of Changes
Other Study ID Numbers: XRP6976J_2503
Study First Received: December 21, 2005
Last Updated: December 4, 2009
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Docetaxel
Antimitotic Agents
Antineoplastic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014