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Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Active
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Bicalutamide
docetaxel
GnRh analog
radiotherapy
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

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

Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate with one of the prognostic factors specified in the protocol. No pelvic lymph node disease that would necessitate pelvic radiotherapy. No radiologic evidence of metastatic disease on bone scan or on CT scan or MRI of the abdomen or pelvis No prior radiation therapy, chemotherapy, immunotherapy or alternative therapy for prostate cancer. Greater than 4 weeks since any major surgery. Performance status 0-2 Must meet criteria for acceptable lab values as outlined in the protocol. Peripheral neuropathy must be greater than or equal to 1 Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. Exclusion Criteria: 1. No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Experimental Arm

    Arm Description

    Outcomes

    Primary Outcome Measures

    Maximum tolerated dose (MTD) of Taxotere with radiation therapy and hormonal therapy
    To determine the MTD of Taxotere with radiation therapy and hormonal therapy in patients with high risk locally advanced adenocarcinoma of the prostate. The dose limiting toxicity (CLT) period for determining the MTD is 57 days.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 8, 2004
    Last Updated
    October 11, 2023
    Sponsor
    Medical University of South Carolina
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00099086
    Brief Title
    Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer
    Official Title
    Phase I Trial of Concurrent Taxotere With Radiation Therapy and Hormonal Therapy For Clinically Localized High Risk Prostate Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Active, not recruiting
    Study Start Date
    January 16, 2007 (Actual)
    Primary Completion Date
    January 20, 2011 (Actual)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Medical University of South Carolina

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This phase I trial is studying the side effects and best dose of docetaxel when given with radiation therapy and hormone therapy in patients with locally advanced prostate cancer.
    Detailed Description
    Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Docetaxel may also make tumor cells more sensitive to radiation therapy. Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, or bicalutamide, may stop the adrenal glands from making androgens. Giving chemotherapy with radiation therapy and hormone therapy may kill more tumor cells.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Arm
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Bicalutamide
    Other Intervention Name(s)
    Casodex
    Intervention Description
    Bicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)
    Intervention Type
    Drug
    Intervention Name(s)
    docetaxel
    Other Intervention Name(s)
    Taxotere
    Intervention Description
    Docetaxel will be administered weekly during radiotherapy. The docetaxel dose will be escalated as part of the study. Dose levels are: 10mg/m2; 15 mg/m2; 20 mg/m2 and 25 mg/m2
    Intervention Type
    Drug
    Intervention Name(s)
    GnRh analog
    Other Intervention Name(s)
    Zoladex, goserelin acetate, leuprolide acetate, Lupron
    Intervention Description
    A GnRH analog (goserelin acetate, leuprolide acetate) will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months) Bicalutamide will be administered for approximately 28 months: prior to radiotherapy (2 months), during radiotherapy (2 months), and after radiotherapy (24 months)
    Intervention Type
    Radiation
    Intervention Name(s)
    radiotherapy
    Intervention Description
    External beam photon radiotherapy utilizing 3-D-conformal or intensity modulated radiotherapy (IMRT) shall be used to deliver 77.4 4 Gy in 43 fractions of 1.8 Gy fractions.
    Primary Outcome Measure Information:
    Title
    Maximum tolerated dose (MTD) of Taxotere with radiation therapy and hormonal therapy
    Description
    To determine the MTD of Taxotere with radiation therapy and hormonal therapy in patients with high risk locally advanced adenocarcinoma of the prostate. The dose limiting toxicity (CLT) period for determining the MTD is 57 days.
    Time Frame
    57 days

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically confirmed adenocarcinoma of the prostate with one of the prognostic factors specified in the protocol. No pelvic lymph node disease that would necessitate pelvic radiotherapy. No radiologic evidence of metastatic disease on bone scan or on CT scan or MRI of the abdomen or pelvis No prior radiation therapy, chemotherapy, immunotherapy or alternative therapy for prostate cancer. Greater than 4 weeks since any major surgery. Performance status 0-2 Must meet criteria for acceptable lab values as outlined in the protocol. Peripheral neuropathy must be greater than or equal to 1 Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter. Exclusion Criteria: 1. No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with Polysorbate 80
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David Marshall, MD
    Organizational Affiliation
    Medical University of South Carolina
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Docetaxel, Radiation Therapy, and Hormone Therapy in Treating Patients With Locally Advanced Prostate Cancer

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