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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00186420
First Posted: September 16, 2005
Last Update Posted: June 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Sandy Srinivas, Stanford University
  Purpose
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 Intervention Phase
Prostate Cancer Drug: Taxotere Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Sandy Srinivas, Stanford University:

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

Enrollment: 13
Study Start Date: July 2003
Study Completion Date: September 2009
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
United States, California
Stanford University Cancer Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Aventis Pharmaceuticals
Investigators
Principal Investigator: Sandy Srinivas, MD Stanford University
  More Information

Responsible Party: Sandy Srinivas, Associate Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00186420     History of Changes
Other Study ID Numbers: PROS0004
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by Sandy Srinivas, Stanford University:
Prostate Cancer
Taxotere

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action