Conditions: Prostate Cancer
Keywords: Prostate Androgen AIPC Doxil
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

Brief 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.

Detailed description:
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.

Arms:
arm 1: Combination of Thalidomide and Doxil

Interventions: intervention 1: Thalidomide intervention 2: Doxil
Intervention descriptions: intervention 1: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg intervention 2: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days

Protocol document: