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Sponsors and Collaborators: |
California Cancer Consortium National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00080899 |
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 biochemically (rising PSA level) recurrent hormone-naïve (no previous hormone therapy) prostate cancer.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: fenretinide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial Of Fenretinide (4-HPR) In Biochemically Recurrent, Hormone Naive Prostate Cancer |
Estimated Enrollment: | 37 |
Study Start Date: | June 2004 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (surgery vs radiotherapy and/or brachytherapy vs both), stage at diagnosis (organ confined vs extra-capsular extension vs lymph node positive), Gleason score at diagnosis (2-4 vs 5-6 vs 7-10), and prostate-specific antigen level at diagnosis (0-4 ng/mL vs 4.1-10 ng/mL vs > 10 ng/mL).
Patients receive oral fenretinide twice daily on days 1-7. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 12-37 patients will be accrued for this study.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Rising prostate-specific antigen (PSA) (absolute PSA value > 2.0 ng/mL above the nadir) after a nadir (< 4 ng/mL for post-radiotherapy patients and 0.3 ng/mL for post-prostatectomy patients) after local curative therapy (radical prostatectomy and/or pelvic irradiation)
No clinical or radiographic evidence of metastatic or locally recurrent disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
No uncontrolled seizure disorder
No known uncontrolled hypertriglyceridemia resulting in pancreatitis
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 | |
Tower Cancer Research Foundation | |
Beverly Hills, California, United States, 90211 | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90089-9181 | |
United States, Pennsylvania | |
Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
Pittsburgh, Pennsylvania, United States, 15232 |
Study Chair: | Jacek Pinski, MD | USC/Norris Comprehensive Cancer Center |
Study ID Numbers: | CDR0000357312, CCC-PHII-47, NCI-6168 |
Study First Received: | April 7, 2004 |
Last Updated: | May 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00080899 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate recurrent prostate cancer stage II prostate cancer stage III prostate cancer |
Anticarcinogenic Agents Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Fenretinide |
Genital Diseases, Male Adenocarcinoma Hormones Prostatic Neoplasms Recurrence |
Anticarcinogenic Agents Genital Neoplasms, Male Prostatic Diseases Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Genital Diseases, Male |
Protective Agents Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Fenretinide Prostatic Neoplasms |