Thalidomide and Doxil® in Patients With Androgen Independent Prostate Cancer (AIPC)
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Thalidomide; Doxil
Intervention description: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg; On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days
Intervention MeSH terms: Thalidomide; Doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Prostate; Androgen; AIPC; Doxil

Summary:

      The primary objective of this study is to evaluate PSA response rates of the combination of
      Doxil and Thalidomide in patients with AIPC who have failed chemotherapy. Secondary
      objectives include: 1) To evaluate the clinical response rate of this combination on
      measurable disease 2) To evaluate overall survival for this combination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed adenocarcinoma of the prostate.

          -  Confirmed androgen independent prostate cancer with evidence of rising PSA (two
             successive increases in PSA, at least 4 weeks apart) while on chemotherapy. If the PSA
             is less than 5, the increase in PSA must be at least 50%. Must also have castrate
             testosterone levels (<50 ng/ml)

          -  Patients could not have received more than 2 previous chemotherapy regimens.

          -  No anthracyclines within the past 6 months.

          -  No prior single agent thalidomide in the last 12 months. No prior cytotoxic
             chemotherapy + thalidomide given in conjunction

          -  Age > 18 years of age

          -  Performance status ECOG 0-2

          -  Peripheral neuropathy must be < grade 1

          -  Must have adequate hematologic, hepatic and renal function

          -  Men of reproductive potential must be willing to consent to using effective
             contraception while on treatment and for at least 4 weeks thereafter

          -  Patients must have left ventricular ejection fraction of > 50% within 42 days prior to
             first dose of study drug. The method used at baseline must be used for later
             monitoring

          -  Must have been off an anti-androgen for at least 4-6 weeks (Flutamide and Bicalutamide
             respectively) and documented as having a rising PSA

          -  Measurable or evaluable disease (PSA elevation will constitute evaluable disease).
             Measurable disease is defined as at least one lesion that can be accurately measured
             in at least one dimension (longest diameter to be recorded) as >20 mm with
             conventional techniques CT scan or as >10 mm with spiral CT scan. See section 6.B for
             the evaluation of measurable disease

          -  Life expectancy of greater than 3 months

          -  Patients must be willing and able to comply with the FDA-mandated S.T.E.P.S.® program

          -  Ability to understand and sign written informed consent approved by the Institutional
             Review Board [IRB/Ethics Committee], which will be obtained prior to study entry.

        Exclusion Criteria:

          -  Patients with unstable angina, uncompensated CHF, a history of an MI, PE or DVT within
             the last 3 months