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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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
Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Response Rate
The number of patients experiencing a response to treatment, per RECIST criteria / total number of patients evaluable for response.
Time frame: 24 weeks
Best Overall PSA Response
PSA response as stable disease or progressive disease, per Prostate-Specific Antigen Working Group criteria.
Time frame: 4 weeks
Overall Survival
Time frame: 36 months
Time to Progression
Time from start of treatment until the disease progression per RECIST criteria.
Time frame: Up to 18 months
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