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

This is an open label, Phase II trial of thalidomide and Doxil in patients with androgen
independent prostate cancer whom have a rising PSA while on chemotherapy. 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 (If
measurable soft tissue lesions are present on radiological or clinical exam) ; 2) To evaluate
overall survival for this combination. There will be between 18 and 35 subjects at least 18
years of age enrolled on this single site study.

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