Clinical trial NCT00060437 (phase 2, status: completed)
Conditions: prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: perifosine
SMILES: CCCCCCCCCCCCCCCCCCOP([O-])(=O)OC1CC[N+](C)(C)CC1
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