Perifosine in Treating Patients With Metastatic, Androgen-Independent Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
OBJECTIVES: Determine the 4-month progression-free survival rate, as measured by prostate-specific antigen and clinical criteria, in patients with metastatic androgen-independent prostate cancer treated with perifosine. Determine the side-effect profile of this drug in these patients. Determine the pharmacokinetics and pharmacodynamics of this drug in these patients. OUTLINE: Course 1: Patients receive oral perifosine twice on day 1 and once daily on days 2-21. All subsequent courses: Patients receive oral perifosine once daily on days 1-21. 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.

Official Title
-----------------
A Phase II Trial Of Oral Perifosine In Patients With Metastatic Androgen Independent Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: perifosine


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate, meeting all of the following criteria: Metastatic Androgen-independent Progressive disease while continuing to receive hormonal ablation (e.g., luteinizing hormone-releasing hormone [LHRH] agonist) Progression documented by at least 1 of the following parameters: Two consecutively rising prostate-specific antigen levels, at least 1 week apart, with at least 1 measurement that is 50% above the nadir reached after the last treatment regimen (as long as the last measurement is at least 5 ng/mL) At least 1 new metastatic lesion on technetium Tc 99m bone scintigraphy Progression of soft-tissue metastases as measured by appropriate modalities (i.e., imaging or palpation) and demonstrated by at least 1 of the following: Development of new area of malignant disease (measurable or nonmeasurable) At least a 20% increase in the sum of the longest diameters (LD) of target lesions from the smallest sum of LD recorded since the treatment started or the appearance of 1 or more new lesions Patients who have not undergone surgical castration must have a testosterone level less than 50 ng/mL and continue on their LHRH agonist during study treatment No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy More than 3 months Hematopoietic WBC at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin less than 1.0 mg/dL or upper limit of normal (ULN) AST/ALT no greater than 2.5 times ULN Renal Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular No myocardial infarction within the past 6 months No unstable or newly diagnosed angina pectoris No New York Heart Association class II-IV congestive heart failure Ophthalmic No pre-existing retinal disease No pathologic baseline electrooculogram Other Fertile patients must use effective barrier contraception Able to ingest oral medication No prior allergic reactions attributed to compounds of similar chemical or biological composition to perifosine (e.g., miltefosine or edelfosine) No ongoing or active infection No other concurrent uncontrolled illness No psychiatric illness or social situation that would preclude study compliance No other active malignancies within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the bladder PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No more than 1 prior chemotherapy regimen More than 4 weeks since prior chemotherapy (at least 6 weeks for nitrosoureas or mitomycin) Endocrine therapy See Disease Characteristics More than 4 weeks since prior flutamide More than 6 weeks since prior bicalutamide or nilutamide Radiotherapy At least 6 weeks since prior bone-seeking radioisotopes Recovered from prior radiotherapy Surgery See Disease Characteristics Recovered from prior surgery Other Recovered from any acute toxicity related to prior therapy More than 3 months since prior UCN-01 More than 3 months since prior suramin No concurrent commercial or other investigational agents or therapies intended to treat the malignancy No concurrent combination antiretroviral therapy for HIV-positive patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: perifosine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IV prostate cancer, recurrent prostate cancer, adenocarcinoma of the prostate