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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00077402
First Posted: February 12, 2004
Last Update Posted: May 15, 2013
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:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Prostate Cancer Drug: fenretinide Phase 2

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study Of Fenretinide In Patients With Hormone Refractory Prostate Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Response rate as measured by RECIST at ≥ 9 weeks

Secondary Outcome Measures:
  • Toxicity as measured by NCI CTC

Estimated Enrollment: 50
Study Start Date: November 2003
Study Completion Date: February 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  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): NCT00077402


Locations
Australia, New South Wales
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Australia, Western Australia
Sir Charles Gairdner Hospital - Perth
Perth, Western Australia, Australia, 6009
Hong Kong
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
Singapore
Cancer Institute at National University Hospital
Singapore, Singapore, 119074
National Cancer Centre - Singapore
Singapore, Singapore, 169610
Johns Hopkins Singapore International Medical Centre
Singapore, Singapore, 308433
Sponsors and Collaborators
Cancer Therapeutics Research Group
National Cancer Institute (NCI)
Investigators
Study Chair: Michael Boyer Sydney Cancer Centre at Royal Prince Alfred Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00077402     History of Changes
Other Study ID Numbers: CTRG-P18/02
CDR0000350305 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-6062
First Submitted: February 10, 2004
First Posted: February 12, 2004
Last Update Posted: May 15, 2013
Last Verified: December 2006

Keywords provided by National Cancer Institute (NCI):
recurrent prostate cancer
stage III prostate cancer
stage IV prostate cancer
adenocarcinoma of the prostate

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs