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Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation

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ClinicalTrials.gov Identifier: NCT00186420
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : June 13, 2012
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University

Study Description
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Brief Summary:
The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Taxotere Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Adjuvant Taxotere in Patients With High Risk Prostate Cancer Post Prostatectomy and Radiation
Study Start Date : July 2003
Actual Primary Completion Date : January 2006
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Docetaxel

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy. [ Time Frame: Following treatment ]

Secondary Outcome Measures :
  1. To evaluate the toxicity of taxotere and hormones given adjuvantly. [ Time Frame: Following treatment ]
  2. To measure Quality of Life on this therapy. [ Time Frame: Following treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who have undergone a radical prostatectomy (should have unmeasurable PSA) or radiation therapy for prostate cancer and who have high risk disease as defined by one of the following:

    • Node positive disease post-operatively
    • Capsule involvement
    • Seminal Vesicles involvement
    • Gleason score ≥ 8
    • >50% of core biopsies that are positive
    • Clinical Stage T2c and T3

    • Pre-op PSA > 15 plus Gleason score of 7

      • Age greater than 18
      • ECOG Performance Status 0-1
      • Serum creatinine <= 1.5 mg/dl
      • Granulocyte count >= 1500/m3, Hemoglobin > 8.0 g/dl, and platelet count >= 100,000/m3
      • Total bilirubin <= ULN
      • AST, ALT and Alkaline Phosphatase must be within the range allowing for eligibility.
      • Signed patient informed consent.
      • Men of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months thereafter.

Exclusion Criteria:

  • Peripheral neuropathy > grade 1
  • History of severe hypersensitivity to Taxotere® or other drugs formulated with polysorbate 80.
  • Patients who have received previous chemotherapy or are being treated on another clinical trial using an investigational agent.
  • Active infection within 14 days of beginning treatment
  • Patients with a serious illness or medical condition, history of significant neurologic or psychiatric or active infection.
  • Patients with a current malignancy. Patients with prior a history of in situ lobular carcinoma of the breast, basal or squamous cell skin cancer, are eligible.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186420


Locations
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United States, California
Stanford University Cancer Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Aventis Pharmaceuticals
Investigators
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Principal Investigator: Sandy Srinivas, MD Stanford University
More Information
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Responsible Party: Sandy Srinivas, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00186420    
Other Study ID Numbers: PROS0004
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: June 13, 2012
Last Verified: June 2012
Keywords provided by Sandy Srinivas, Stanford University:
Prostate Cancer
Taxotere
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
 Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action