Trilostane for Androgen-Independent Prostate Cancer

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00181597
First received: September 9, 2005
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Prostate Cancer
Prostate Adenocarcinoma
Drug: Trilostane
Drug: Hydrocortisone
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Trilostane for Androgen-Independent Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • activity of trilostane in men with androgen-independent prostate cancer. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • serum levels of gonadal and adrenal steroids [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: March 2004
Study Completion Date: January 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Trilostane
    Taken orally once a day for three days then twice daily thereafter.
    Drug: Hydrocortisone
    Taken orally with trilostane.
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181597

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

No publications provided

Responsible Party: Medical Monitor, Genzyme
ClinicalTrials.gov Identifier: NCT00181597     History of Changes
Other Study ID Numbers: 04-037
Study First Received: September 9, 2005
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Sanofi:
Trilostane
Androgen-independent prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Adenocarcinoma
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Androgens
Hydrocortisone
Trilostane
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Abortifacient Agents, Steroidal
Abortifacient Agents
Reproductive Control Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014