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Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin in the Treatment of Hormone Refractory Prostate Carcinoma

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Paclitaxel
Estramustine
Carboplatin
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)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adenocarcinoma of the prostate not curable with local treatment Disease progression while receiving hormonal therapy Measurable or evaluable disease Previous treatment with a maximum of one prior chemotherapy regimen ECOG performance status 0, 1, or 2. Adequate bone marrow, liver and kidney function Able to comprehend the nature of this study and give written informed consent Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age < 18 years History of treatment for an invasive malignancy within five years Significant heart disease 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

    Overall response rate

    Secondary Outcome Measures

    Toxicity
    Overall survival

    Full Information

    First Posted
    September 12, 2005
    Last Updated
    August 3, 2010
    Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Bristol-Myers Squibb
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00193193
    Brief Title
    Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin in the Treatment of Hormone Refractory Prostate Carcinoma
    Official Title
    A Randomized, Phase II Trial of Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin Administered Either Weekly or Every Four Weeks in the Treatment of Hormone Refractory Prostate Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2010
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2000 (undefined)
    Primary Completion Date
    December 2003 (Actual)
    Study Completion Date
    February 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    SCRI Development Innovations, LLC
    Collaborators
    Bristol-Myers Squibb

    4. Oversight

    5. Study Description

    Brief Summary
    In this trial we will investigate how this three-drug regimen may be improved, both with respect to efficacy and toxicity, by making some modifications in the dosing and schedule in the treatment of patients with hormone refractory prostate cancer.
    Detailed Description
    Upon determination of eligibility, patients will receive: Paclitaxel + Estramustine + Carboplatin Patients will receive weekly paclitaxel and low-dose estramustine, in combination with carboplatin administered either weekly r every four weeks.

    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
    100 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Paclitaxel
    Intervention Type
    Drug
    Intervention Name(s)
    Estramustine
    Intervention Type
    Drug
    Intervention Name(s)
    Carboplatin
    Primary Outcome Measure Information:
    Title
    Overall response rate
    Secondary Outcome Measure Information:
    Title
    Toxicity
    Title
    Overall survival

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adenocarcinoma of the prostate not curable with local treatment Disease progression while receiving hormonal therapy Measurable or evaluable disease Previous treatment with a maximum of one prior chemotherapy regimen ECOG performance status 0, 1, or 2. Adequate bone marrow, liver and kidney function Able to comprehend the nature of this study and give written informed consent Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age < 18 years History of treatment for an invasive malignancy within five years Significant heart disease 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

    Learn more about this trial

    Weekly Paclitaxel, Low-Dose Estramustine, and Carboplatin in the Treatment of Hormone Refractory Prostate Carcinoma

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