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

June 12, 2012 updated by: Sandy Srinivas, Stanford University
The purpose of this study is to evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To evaluate time to progression (TTP) by PSA in patients with high risk prostate cancer after definitive therapy.
Time Frame: Following treatment
Following treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate the toxicity of taxotere and hormones given adjuvantly.
Time Frame: Following treatment
Following treatment
To measure Quality of Life on this therapy.
Time Frame: Following treatment
Following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Aventis Pharmaceuticals

Investigators

  • Principal Investigator: Sandy Srinivas, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2003

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

June 13, 2012

Last Update Submitted That Met QC Criteria

June 12, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROS0004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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