Clinical trial NCT00058214 (phase 2, status: terminated)
Conditions: adenocarcinoma of the prostate, recurrent prostate cancer, stage iib prostate cancer, stage iii prostate cancer, stage iv prostate cancer
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: perifosine
SMILES: CCCCCCCCCCCCCCCCCCOP([O-])(=O)OC1CC[N+](C)(C)CC1
Reason stopped: 
    did not meet interim stopping criteria for continuation to the second stage.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed adenocarcinoma of the
             prostate

          -  Patients must have a rising PSA >= 2.0 following a nadir after local curative therapy
             (either radical prostatectomy and/or pelvic radiation) with no clinical or
             radiographic evidence of metastatic disease; PSA >= 2.0 elevation must be confirmed by
             two consecutive increases, each measured at least 2 weeks apart; only patients with a
             biochemical (PSA) recurrence with no physical exam or radiographic evidence of local
             or distant relapse are eligible

          -  Prior hormonal therapy in the form of neoadjuvant or adjuvant therapy is allowed as
             long as neither lasted for more than 9 months; androgen deprivation therapy must have
             been completed at least one year prior to registration; patients could not have had a
             rising PSA at the time that neoadjuvant or adjuvant therapy was stopped

          -  Life expectancy of greater than 3 months

          -  Karnofsky performance status > 60%

          -  Leukocytes >= 3,000/uL

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,00/uL

          -  Total bilirubin =< 1.5 mg/dL

          -  AST (SGOT)/ALT (SGPT) =< 2.5 x institutional upper limit of normal

          -  Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min

          -  Computed tomography scan or MRI of the pelvis negative for metastatic disease within 3
             months prior to registration

          -  Bone scan negative for metastatic disease within 3 months prior to registration

          -  Chest PA and lateral films negative for metastatic disease within 3 months prior to
             registration

          -  Prior vaccine therapy is allowed if completed at least 6 months prior to registration

          -  Men enrolled in this trial must agree to use adequate contraception prior to study
             entry and for the duration of study participation

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients who have had any prior cytotoxic chemotherapy

          -  Patients may not be receiving any other investigational agents

          -  Patients receiving concurrent chemotherapeutic agents, biological response modifiers,
             radiation therapy, corticosteroid or hormonal therapy; no complementary or alternative
             therapy (e.g., St. John's Wort, PC-SPES, or any other herbal remedies taken for the
             purpose of treating prostate cancer) may be given during protocol treatment

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to perifosine

          -  Androgen deprivation given for reasons other than neoadjuvant or adjuvant therapy

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  HIV-positive patients receiving combination anti-retroviral therapy are excluded from
             the study because of possible pharmacokinetic interactions with perifosine;
             appropriate studies will be undertaken in patients receiving combination
             anti-retroviral therapy when indicated

          -  No prior malignancy is allowed except for the following: adequately treated basal cell
             or squamous cell skin cancer, in situ carcinoma of any site, adequately treated stage
             I or II cancer from which the patient is currently in complete remission, or any other
             cancer from which the patient has been disease-free for 5 years