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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
fenretinide
Sponsored by
Cancer Therapeutics Research Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sydney Cancer Centre at Royal Prince Alfred Hospital
  • Sir Charles Gairdner Hospital - Perth
  • Prince of Wales Hospital
  • Cancer Institute at National University Hospital
  • National Cancer Centre - Singapore
  • Johns Hopkins Singapore International Medical Centre

Outcomes

Primary Outcome Measures

Response rate as measured by RECIST at ≥ 9 weeks

Secondary Outcome Measures

Toxicity as measured by NCI CTC

Full Information

First Posted
February 10, 2004
Last Updated
May 14, 2013
Sponsor
Cancer Therapeutics Research Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00077402
Brief Title
Fenretinide In Treating Patients With Advanced or Metastatic Hormone-Refractory Prostate Cancer
Official Title
A Phase 2 Study Of Fenretinide In Patients With Hormone Refractory Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
November 2003 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Cancer Therapeutics Research Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
recurrent prostate cancer, stage III prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
fenretinide
Primary Outcome Measure Information:
Title
Response rate as measured by RECIST at ≥ 9 weeks
Secondary Outcome Measure Information:
Title
Toxicity as measured by NCI CTC

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Boyer
Organizational Affiliation
Sydney Cancer Centre at Royal Prince Alfred Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Sydney Cancer Centre at Royal Prince Alfred Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Sir Charles Gairdner Hospital - Perth
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Prince of Wales Hospital
City
Shatin, New Territories
Country
Hong Kong
Facility Name
Cancer Institute at National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
National Cancer Centre - Singapore
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Johns Hopkins Singapore International Medical Centre
City
Singapore
ZIP/Postal Code
308433
Country
Singapore

12. IPD Sharing Statement

Citations:
PubMed Identifier
20082080
Citation
Moore MM, Stockler M, Lim R, Mok TS, Millward M, Boyer MJ. A phase II study of fenretinide in patients with hormone refractory prostate cancer: a trial of the Cancer Therapeutics Research Group. Cancer Chemother Pharmacol. 2010 Oct;66(5):845-50. doi: 10.1007/s00280-009-1228-x. Epub 2010 Jan 16.
Results Reference
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Fenretinide In Treating Patients With Advanced or Metastatic Hormone-Refractory Prostate Cancer

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