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

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
docetaxel
Sponsored by
Sanofi
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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 : Hematology: Neutrophils ≥ 1.5 x 10^9/L Hemoglobin > 10 g/dL (prior transfusion permitted). Platelets ≥ 100 x 10^9/L 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. 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Pain (pain progression evaluated with the Present Pain Intensity scale form McGill-Melzack questionnaire)

    Secondary Outcome Measures

    Analgesics (assessed by Pain Medication Log)
    PSA (PSA response and PSA progression
    Tumor lesion assessment,
    Overall survival
    Progression-free survival
    Treatment emergent adverse events recorded by the investigator where intensity was according to NCI-CTC criteria: Standard hematology, blood chemistry and clinical exams.

    Full Information

    First Posted
    December 21, 2005
    Last Updated
    December 4, 2009
    Sponsor
    Sanofi
    Collaborators
    Canadian Urologic Oncology Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00268710
    Brief Title
    Docetaxel in Hormone Refractory Prostate Cancer (HRPC)[Weekly or 3weekly TAX + Prednisone in HRPC]
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2004 (undefined)
    Primary Completion Date
    March 2006 (Actual)
    Study Completion Date
    March 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Sanofi
    Collaborators
    Canadian Urologic Oncology Group

    4. Oversight

    5. Study Description

    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®.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostatic Neoplasms

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    docetaxel
    Primary Outcome Measure Information:
    Title
    Pain (pain progression evaluated with the Present Pain Intensity scale form McGill-Melzack questionnaire)
    Time Frame
    During the Study Conduct
    Secondary Outcome Measure Information:
    Title
    Analgesics (assessed by Pain Medication Log)
    Time Frame
    During the study conduct
    Title
    PSA (PSA response and PSA progression
    Time Frame
    During the study conduct
    Title
    Tumor lesion assessment,
    Time Frame
    During the study conduct
    Title
    Overall survival
    Time Frame
    During the study conduct
    Title
    Progression-free survival
    Time Frame
    During the study conduct
    Title
    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

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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 : Hematology: Neutrophils ≥ 1.5 x 10^9/L Hemoglobin > 10 g/dL (prior transfusion permitted). Platelets ≥ 100 x 10^9/L 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. 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Monique Furlan
    Organizational Affiliation
    Sanofi
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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