Thalidomide and Doxil® in Patients With Androgen Independent Prostate Cancer (AIPC)

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