Expired Study
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Bethesda, Maryland 20892


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.


Study summary:

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.


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


NCT ID:

NCT00060437


Primary Contact:

Study Chair
Edwin M. Posadas, MD
National Cancer Institute (NCI)


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 12, 2017

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