Status:
COMPLETED
Fenretinide In Treating Patients With Advanced or Metastatic Hormone-Refractory Prostate Cancer
Lead Sponsor:
Cancer Therapeutics Research Group
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 fen...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00077402
Start Date
November 1 2003
End Date
February 1 2011
Last Update
May 15 2013
Active Locations (6)
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1
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
2
Sir Charles Gairdner Hospital - Perth
Perth, Western Australia, Australia, 6009
3
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
4
Cancer Institute at National University Hospital
Singapore, Singapore, 119074