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Docetaxel and Diethylstilbestrol in the Treatment of Androgen Independent Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Docetaxel and Diethylstilbestrol (DES)
Sponsored by
University of Washington
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate Cancer, Hormone refractory prostate cancer, Metastatic prostate cancer

Eligibility Criteria

21 Years - 83 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Patients meeting all of the following criteria are eligible for the trial: Men 18 years of age or older with a histologically confirmed diagnosis of adenocarcinoma of the prostate consistent with stage D3. Prior therapy with medical or surgical castration and evidence of castrate levels of testosterone Discontinuation of nonsteroidal antiandrogens more than 6 weeks prior to evaluation for progression. It is not a requirement that nonsteroidal antiandrogen therapy be used prior to enrollment. Androgen independent disease as defined by one of the following after androgen ablation and withdrawal from nonsteroidal antiandrogen if initiated (> 6 weeks after discontinuation): PSA must be greater than 5 ng/ml and increasing as demonstrated by two consecutive increasing PSA levels over 5 ng/ml. Each PSA measurement must be taken at least one week apart. Increase in measurable disease within one month of enrollment Worsening of bone scan abnormalities within two months of enrollment and greater than four months since initiation of luteinizing hormone-releasing hormone (LHRH) agonist. Performance status < 3 by the Eastern Cooperative Oncology Group (ECOG) scale. Patients must be informed of the investigational nature of the study and sign an informed consent form. Life expectancy must be >= 3 months. Laboratory values must be as follows: White blood cell count: >= 3,000/mm3 Absolute granulocyte count: >= 1,500/mm3 Platelets: >= 100,000/mm3 Hemoglobin: >= 8g/dL Serum creatinine: <= 1.5 x upper limit of normal (ULN) AST: <= 2 x ULN ALT: <= 2 x ULN Serum calcium: <= ULN Total bilirubin: <= 1.5 x ULN Patient must be willing to consent to using effective contraception while on treatment and for three months after completion of therapy. Exclusion Criteria: Patients meeting any of the following criteria will not be eligible for the trial: Patients who have received PC-SPES, DES, mitoxantrone or docetaxel therapy. Patients who have received prior chemotherapy of any type or are receiving any other investigational therapy. Patients with evidence of recent deep venous thrombosis, pulmonary emboli, unstable angina or clinical congestive heart failure. Patients with a prior history of myocardial infarction, pulmonary embolism, cerebral vascular accident (CVA) or atrial fibrillation. Patients with evidence of active angina as evidenced by chest pain responsive to sublingual nitroglycerin or other anginal equivalent. Patients with known evidence of brain metastases or carcinomatous meningitis. Patients with a history of other cancers except curatively-treated non-melanomatous skin cancer. Other cured tumors may be entered after discussion with and approval of the study chair. Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment. Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent. Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 must be excluded. Histologic evidence of small cell carcinoma of the prostate. Patients with current peripheral neuropathy of any etiology that is greater than Grade I. Patients with contraindications to anti-coagulation.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Monthly PSA levels and scans every 3 months while on therapy

    Secondary Outcome Measures

    To evaluate the time to progression of disease
    To determine the risk of cardiovascular complications associated with DES plus aspirin and warfarin 2 mg daily
    To measure this regimen's toxicity and impact on quality of life measures

    Full Information

    First Posted
    August 25, 2005
    Last Updated
    May 7, 2013
    Sponsor
    University of Washington
    Collaborators
    Sanofi
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00136526
    Brief Title
    Docetaxel and Diethylstilbestrol in the Treatment of Androgen Independent Prostate Cancer
    Official Title
    Docetaxel and Diethylstilbestrol in the Treatment of Androgen Independent Prostate Cancer: A Phase II Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Washington
    Collaborators
    Sanofi

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is for men who have prostate cancer that has spread outside of the prostate gland and is no longer responding to hormone removal therapy. This study is designed to determine if a new drug combination will help to control the cancer. The medicines being used, docetaxel and diethylstilbestrol (DES), have been given to patients with prostate cancer and each drug has demonstrated activity in prostate cancer, either used alone or in other combinations. The objective of this study is to determine the effect of this drug combination on the prostate cancer and its response to disease progression.
    Detailed Description
    This is a single arm phase II trial of docetaxel and diethylstilbestrol for patients with symptomatic stage D3 androgen independent prostate cancer. Patients will receive docetaxel weekly for 10 cycles (each cycle consists of treatment for 3 weeks out of every 4) and DES daily for 40 weeks or until there is evidence of disease progression, whichever occurs first. Patients will be followed to determine PSA and objective response. Additional endpoints include time to progression, disease specific survival and overall survival. Disease progression will be defined as 2 consecutive increases in PSA and/or tumor growth as evidenced by examination or radiologic evaluation. Other secondary objectives will be to determine the toxicity, and impact on quality of life of this regimen.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostate Cancer
    Keywords
    Prostate Cancer, Hormone refractory prostate cancer, Metastatic 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
    30 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Docetaxel and Diethylstilbestrol (DES)
    Intervention Description
    Subjects receive docetaxel 36 Mg/m2weekly for ten cycles (3 weeks out of every 4) and DES 1 mg daily for 40 weeks or until there is evidence of disease progression, whichever occurs first.
    Primary Outcome Measure Information:
    Title
    Monthly PSA levels and scans every 3 months while on therapy
    Time Frame
    Over 10 months
    Secondary Outcome Measure Information:
    Title
    To evaluate the time to progression of disease
    Time Frame
    Follow-up until progression
    Title
    To determine the risk of cardiovascular complications associated with DES plus aspirin and warfarin 2 mg daily
    Time Frame
    Over 10 months while on therapy
    Title
    To measure this regimen's toxicity and impact on quality of life measures
    Time Frame
    Over 10 months while on therapy

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    83 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients meeting all of the following criteria are eligible for the trial: Men 18 years of age or older with a histologically confirmed diagnosis of adenocarcinoma of the prostate consistent with stage D3. Prior therapy with medical or surgical castration and evidence of castrate levels of testosterone Discontinuation of nonsteroidal antiandrogens more than 6 weeks prior to evaluation for progression. It is not a requirement that nonsteroidal antiandrogen therapy be used prior to enrollment. Androgen independent disease as defined by one of the following after androgen ablation and withdrawal from nonsteroidal antiandrogen if initiated (> 6 weeks after discontinuation): PSA must be greater than 5 ng/ml and increasing as demonstrated by two consecutive increasing PSA levels over 5 ng/ml. Each PSA measurement must be taken at least one week apart. Increase in measurable disease within one month of enrollment Worsening of bone scan abnormalities within two months of enrollment and greater than four months since initiation of luteinizing hormone-releasing hormone (LHRH) agonist. Performance status < 3 by the Eastern Cooperative Oncology Group (ECOG) scale. Patients must be informed of the investigational nature of the study and sign an informed consent form. Life expectancy must be >= 3 months. Laboratory values must be as follows: White blood cell count: >= 3,000/mm3 Absolute granulocyte count: >= 1,500/mm3 Platelets: >= 100,000/mm3 Hemoglobin: >= 8g/dL Serum creatinine: <= 1.5 x upper limit of normal (ULN) AST: <= 2 x ULN ALT: <= 2 x ULN Serum calcium: <= ULN Total bilirubin: <= 1.5 x ULN Patient must be willing to consent to using effective contraception while on treatment and for three months after completion of therapy. Exclusion Criteria: Patients meeting any of the following criteria will not be eligible for the trial: Patients who have received PC-SPES, DES, mitoxantrone or docetaxel therapy. Patients who have received prior chemotherapy of any type or are receiving any other investigational therapy. Patients with evidence of recent deep venous thrombosis, pulmonary emboli, unstable angina or clinical congestive heart failure. Patients with a prior history of myocardial infarction, pulmonary embolism, cerebral vascular accident (CVA) or atrial fibrillation. Patients with evidence of active angina as evidenced by chest pain responsive to sublingual nitroglycerin or other anginal equivalent. Patients with known evidence of brain metastases or carcinomatous meningitis. Patients with a history of other cancers except curatively-treated non-melanomatous skin cancer. Other cured tumors may be entered after discussion with and approval of the study chair. Patients with an active serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment. Dementia or significantly altered mental status that would prohibit the understanding and/or giving of informed consent. Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 must be excluded. Histologic evidence of small cell carcinoma of the prostate. Patients with current peripheral neuropathy of any etiology that is greater than Grade I. Patients with contraindications to anti-coagulation.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Bruce Montgomery, MD
    Organizational Affiliation
    University of Washington
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Docetaxel and Diethylstilbestrol in the Treatment of Androgen Independent Prostate Cancer

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