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| Sponsor: | California Cancer Consortium |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | California Cancer Consortium |
| ClinicalTrials.gov Identifier: | NCT00058214 |
Purpose
RATIONALE: Drugs used in chemotherapy such as perifosine use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of perifosine in treating patients who have recurrent prostate cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: perifosine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial Of Perifosine (IND 58, 156; NSC# 639966) In Biochemically Recurrent, Hormone Sensitive Prostate Cancer |
| Study Start Date: | March 2003 |
| 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 with or without brachytherapy vs surgery and radiotherapy) and original combined Gleason score (7 or less vs 8-10).
Patients receive oral perifosine once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.
PROJECTED ACCRUAL: A total of 21-41 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Biochemical recurrence
Rising prostate-specific antigen (PSA) of at least 2.0 ng/mL following a nadir after local curative therapy (radical prostatectomy and/or pelvic radiotherapy)
No clinical or radiographic evidence of metastatic disease by all of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| City of Hope Medical Group | |
| Pasadena, California, United States, 91105 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| United States, Pennsylvania | |
| Hillman Cancer Center at University of Pittsburgh Cancer Institute | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| Study Chair: | Primo N. Lara, MD | University of California, Davis |
More Information
| ClinicalTrials.gov Identifier: | NCT00058214 History of Changes |
| Other Study ID Numbers: | CDR0000287195, CCC-PHII-44, CHNMC-PHII-44-02166, NCI-5978 |
| Study First Received: | April 7, 2003 |
| Last Updated: | October 4, 2010 |
| Health Authority: | United States: Federal Government |
|
adenocarcinoma of the prostate recurrent prostate cancer |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site |
Neoplasms Genital Diseases, Male Prostatic Diseases |