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Sponsors and Collaborators: |
Cancer Therapeutics Research Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077402 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase 2 Study Of Fenretinide In Patients With Hormone Refractory Prostate Cancer |
Estimated Enrollment: | 50 |
Study Start Date: | November 2003 |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the prostate
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
At least 6 weeks since prior antiandrogen therapy with any of the following:
Radiotherapy
Other
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 | |
National Cancer Centre - Singapore | |
Singapore, Singapore, 169610 | |
Johns Hopkins Singapore International Medical Centre | |
Singapore, Singapore, 308433 | |
Cancer Institute at National University Hospital | |
Singapore, Singapore, 119074 |
Study Chair: | Michael Boyer | Sydney Cancer Centre at Royal Prince Alfred Hospital |
Study ID Numbers: | CDR0000350305, CTRG-P18/02, NCI-6062 |
Study First Received: | February 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00077402 |
Health Authority: | United States: Federal Government |
recurrent prostate cancer stage III prostate cancer stage IV prostate cancer adenocarcinoma of the prostate |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Fenretinide |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence |
Anticarcinogenic Agents Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Protective Agents Pharmacologic Actions |