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Weekly Docetaxel and Bortezomib in the Treatment of Advanced Hormone-Refractory Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Docetaxel
Bortezomib
Sponsored by
SCRI Development Innovations, LLC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

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

Inclusion Criteria: Prostate cancer, and objective evidence of metastatic disease Progression while receiving androgen ablation therapy No previous chemotherapy Measurable or evaluable disease in conjunction with elevated serum PSA levels ECOG performance status 0, 1, or 2 Adequate bone marrow, liver and kidney function Voluntarily provide written informed consent Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Moderate or severe peripheral neuropathy Age < 18 years Other serious medical conditions that may interfere with protocol therapy Other active malignancies history of treatment for other invasive cancers within 3 years Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    objective response rate

    Secondary Outcome Measures

    progression-free survival
    overall survival

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    July 27, 2010
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Aventis Pharmaceuticals, Millennium Pharmaceuticals, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193232
    Brief Title
    Weekly Docetaxel and Bortezomib in the Treatment of Advanced Hormone-Refractory Prostate Cancer
    Official Title
    A Phase II Trial of Weekly Docetaxel and Bortezomib (Velcade; PS-341) in the Treatment of Patients With Advanced Hormone-Refractory Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2004 (undefined)
    Primary Completion Date
    October 2005 (Actual)
    Study Completion Date
    February 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Aventis Pharmaceuticals, Millennium Pharmaceuticals, Inc.

    4. Oversight

    5. Study Description

    Brief Summary
    Evaluation of the effectiveness of weekly docetaxel/bortezomib as first-line chemotherapy for patients with advanced hormone-refractory prostate cancer.
    Detailed Description
    Upon determination of eligibility, patients will be receive: Docetaxel + Bortezomib Patients with objective responses or stable disease will continue treatment for eight courses or until disease progression is documented.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Docetaxel
    Intervention Type
    Drug
    Intervention Name(s)
    Bortezomib
    Primary Outcome Measure Information:
    Title
    objective response rate
    Secondary Outcome Measure Information:
    Title
    progression-free survival
    Title
    overall survival

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Prostate cancer, and objective evidence of metastatic disease Progression while receiving androgen ablation therapy No previous chemotherapy Measurable or evaluable disease in conjunction with elevated serum PSA levels ECOG performance status 0, 1, or 2 Adequate bone marrow, liver and kidney function Voluntarily provide written informed consent Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Moderate or severe peripheral neuropathy Age < 18 years Other serious medical conditions that may interfere with protocol therapy Other active malignancies history of treatment for other invasive cancers within 3 years Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    John D. Hainsworth, MD
    Organizational Affiliation
    SCRI Development Innovations, LLC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17553208
    Citation
    Hainsworth JD, Meluch AA, Spigel DR, Barton J Jr, Simons L, Meng C, Gould B, Greco FA. Weekly docetaxel and bortezomib as first-line treatment for patients with hormone-refractory prostate cancer: a Minnie Pearl Cancer Research Network phase II trial. Clin Genitourin Cancer. 2007 Mar;5(4):278-83. doi: 10.3816/CGC.2007.n.004.
    Results Reference
    result
    Links:
    URL
    http://cigjournals.metapress.com/content/628584521732211v/?p=9226ef7cd8ae499bae10afa2132095c7&pi=4
    Description
    Published article in Clinical Genitourinary Cancer

    Learn more about this trial

    Weekly Docetaxel and Bortezomib in the Treatment of Advanced Hormone-Refractory Prostate Cancer

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