Fenretinide In Treating Patients With Advanced or Metastatic Hormone-Refractory Prostate Cancer

May 14, 2013 updated by: Cancer Therapeutics Research Group

A Phase 2 Study Of Fenretinide In Patients With Hormone Refractory Prostate Cancer

RATIONALE: Drugs used in chemotherapy, such as fenretinide, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well fenretinide works in treating patients with advanced or metastatic hormone-refractory prostate cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the activity of fenretinide, in terms of the prostate-specific antigen (PSA) response rate, in patients with advanced or metastatic hormone-refractory prostate cancer.

Secondary

  • Determine the objective response rate in patients with identifiable soft tissue disease treated with this drug.
  • Determine the duration of PSA response in patients treated with this drug.
  • Determine PSA progression-free survival of patients treated with this drug.
  • Determine overall survival of patients treated with this drug.
  • Determine the toxicity of this drug in these patients.
  • Determine self-rated symptoms, functions, attitudes to oral therapy, and quality of life of patients treated with this drug.

OUTLINE: This is a multicenter, open-label study.

Patients receive oral fenretinide twice daily on days 1-7. Treatment repeats every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each course, and at the end of therapy.

PROJECTED ACCRUAL: Approximately 21-50 patients will be accrued for this study.

Study Type

Interventional

Enrollment (Anticipated)

50

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

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2050
        • Sydney Cancer Centre at Royal Prince Alfred Hospital
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital - Perth
  • Hong Kong
      • Shatin, New Territories, Hong Kong
        • Prince of Wales Hospital
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre - Singapore
      • Singapore, Singapore, 308433
        • Johns Hopkins Singapore International Medical Centre
      • Singapore, Singapore, 119074
        • Cancer Institute at National University 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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate

    • Measurable or non-measurable disease
    • Metastatic disease allowed
  • Castrate levels of serum testosterone (either after orchiectomy or maintained on a luteinizing hormone-releasing hormone agonist or antagonist)
  • Prostate-specific antigen (PSA) greater than 10 ng/mL at baseline and rising, with 2 consecutive increases measured at least 1 week apart*
  • No known brain metastases NOTE: *If the third PSA value has not risen above the second PSA value, a fourth measurement must be obtained that is higher than the second value

PATIENT CHARACTERISTICS:

Age

  • Over 18

Performance status

  • ECOG 0-1

Life expectancy

  • More than 12 weeks

Hematopoietic

  • Absolute neutrophil count greater than 1,500/mm^3
  • WBC greater than 3,000/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic

  • AST and ALT no greater than 2.5 times upper limit of normal
  • Bilirubin normal

Renal

  • Creatinine normal OR
  • Creatinine clearance greater than 60 mL/min

Cardiovascular

  • No symptomatic congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia

Other

  • Able to tolerate oral medication
  • Fertile patients must use effective contraception
  • No prior allergic reaction to compounds of similar chemical or biological composition to fenretinide
  • No other concurrent uncontrolled illness
  • No ongoing or active infection
  • No psychiatric illness or social situation that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior cytotoxic chemotherapy

Endocrine therapy

  • See Disease Characteristics

  • At least 6 weeks since prior antiandrogen therapy with any of the following:

    • Cyproterone
    • Flutamide
    • Bicalutamide
    • Nilutamide
  • Concurrent corticosteroids allowed provided therapy was initiated before study entry

Radiotherapy

  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy, including for pain
  • No concurrent radioisotopes (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)

Other

  • More than 4 weeks since prior investigational agents
  • No concurrent antioxidants (e.g., ascorbic acid or vitamin E), vitamin A, or beta carotene supplements
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No other concurrent investigational or commercial anticancer agents or therapies

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
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Response rate as measured by RECIST at ≥ 9 weeks

Secondary Outcome Measures

Outcome Measure
Toxicity as measured by NCI CTC

Collaborators and Investigators

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

Sponsor

Cancer Therapeutics Research Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Michael Boyer, Sydney Cancer Centre at Royal Prince Alfred Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2003

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

February 10, 2004

First Submitted That Met QC Criteria

February 11, 2004

First Posted (Estimate)

February 12, 2004

Study Record Updates

Last Update Posted (Estimate)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 14, 2013

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTRG-P18/02
  • CDR0000350305 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-6062

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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