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

NCT00077402 | Completed Phase 2

• 3 other identifiers: CTRG-P18/02CDR0000350305NCI-6062
• Study Type: interventional
• Target: 50
• Locations: 3 countries
• Sites: 6

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.

Conditions

Prostate Cancer

Keywords

recurrent prostate cancer; stage III prostate cancer; stage IV prostate cancer; adenocarcinoma of the prostate

Outcome Measures

Primary Outcomes (1)

• Response rate as measured by RECIST at ≥ 9 weeks

Secondary Outcomes (1)

• Toxicity as measured by NCI CTC

Interventions

fenretinide DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cancer Therapeutics Research Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (6)

Sydney Cancer Centre at Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Sir Charles Gairdner Hospital - Perth

Perth, Western Australia, 6009, Australia

Location

Prince of Wales Hospital

Shatin, New Territories, Hong Kong

Location

Cancer Institute at National University Hospital

Singapore, 119074, Singapore

Location

National Cancer Centre - Singapore

Singapore, 169610, Singapore

Location

Johns Hopkins Singapore International Medical Centre

Singapore, 308433, Singapore

Location

Related Publications (1)

• 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.

  PMID: 20082080 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Fenretinide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Michael Boyer

  Sydney Cancer Centre at Royal Prince Alfred Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 12, 2004
• Study Start: November 1, 2003
• Primary Completion: January 1, 2011
• Study Completion: February 1, 2011
• Last Updated: May 15, 2013

Record last verified: 2006-12

Locations

SG (3); HK (1); AU (2)