Trilostane for Androgen-Independent Prostate Cancer

December 2, 2013 updated by: Genzyme, a Sanofi Company

A Phase II Study of Trilostane for Androgen-Independent Prostate Cancer

The main purpose of this study is to test the safety of trilostane by looking at what effects, good and bad, it has on patients with androgen-independent prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Patients will take trilostane orally once a day for three days, then twice a day thereafter.
  • Patients will complete a daily drug log recording the date, time and number of capsules taken.
  • Trilostane may moderately decrease the production of steroids by the adrenal glands. In order to prevent any symptoms related to decreased steroid production, patients will also take hydrocortisone at the same time as the trilostane.
  • While the patients are on treatment blood work will be done after 2 weeks and then every 4 weeks to test the levels of PSA in the blood. On weeks 4 and 8 of treatment additional blood work will be done to check hormone levels. Blood pressure and pulse rate will also be taken every 4 weeks.
  • Depending upon disease status, radiological testing (CT scan, x-rays, and/or bone scan) may be repeated every 12 weeks.
  • Patients will remain on study treatment as long as their disease responds and they do not experience any severe side effects.

Study Type

Interventional

Enrollment (Actual)

24

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

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:

  • Histologically confirmed prostate adenocarcinoma
  • Disease progression despite androgen depravation therapy and antiandrogen withdrawal
  • Progressive measurable disease or bone scan progression or PSA progression
  • Serum total testosterone < 50ng/ml
  • Creatinine < 2.0 mg/dl
  • ALT < 2 x ULN
  • CALGB performance status of 0,1, or 2

Exclusion Criteria:

  • Radiation therapy within 4 weeks
  • Antiandrogen within 8 weeks
  • Other secondary hormonal therapy or investigational agents within 4 weeks
  • Prior chemotherapy for androgen-independent prostate cancer
  • History of adrenal insufficiency
  • Known brain metastases
  • Severe liver or renal disease

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
activity of trilostane in men with androgen-independent prostate cancer.
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
serum levels of gonadal and adrenal steroids
Time Frame: 4 years
4 years

Collaborators and Investigators

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

Sponsor

Genzyme, a Sanofi Company

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

March 1, 2004

Primary Completion (Actual)

January 1, 2006

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

December 3, 2013

Last Update Submitted That Met QC Criteria

December 2, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04-037

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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