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| Sponsor: | National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00060437 |
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 prostate cancer that no longer responds to androgen ablation therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: perifosine |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| Official Title: | A Phase II Trial Of Oral Perifosine In Patients With Metastatic Androgen Independent Prostate Cancer |
| Study Start Date: | October 2003 |
OBJECTIVES:
OUTLINE:
In all courses, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within approximately 1.5 years.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate, meeting all of the following criteria:
Progression documented by at least 1 of the following parameters:
Progression of soft-tissue metastases as measured by appropriate modalities (i.e., imaging or palpation) and demonstrated by at least 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Ophthalmic
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Contacts and Locations| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Edwin M. Posadas, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000301951, NCI-03-C-0157, NCI-5970 |
| Study First Received: | May 6, 2003 |
| Last Updated: | December 13, 2008 |
| ClinicalTrials.gov Identifier: | NCT00060437 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV prostate cancer recurrent prostate cancer adenocarcinoma of the prostate |
|
Neoplasms Neoplasms by Site Prostatic Diseases Genital Neoplasms, Male Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists |
Urogenital Neoplasms Genital Diseases, Male Hormones Prostatic Neoplasms Pharmacologic Actions Androgens |