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

Study Overview
=================
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.

Official Title
-----------------
Phase II Trial of Thalidomide and Doxil® (Doxorubicin HCL Liposome Injection) in Patients With Androgen Independent Prostate Cancer (AIPC) With a Rising PSA While on Chemotherapy

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: Thalidomide
* Drug: Doxil


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: thalidomide and doxil<br>Combination of Thalidomide and Doxil | Drug: Thalidomide<br>* 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg<br>* Other names: Thalomid;Drug: Doxil<br>* On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days<br>* Other names: doxorubicin liposome;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate | The number of patients experiencing a response to treatment, per RECIST criteria / total number of patients evaluable for response. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Overall PSA Response | PSA response as stable disease or progressive disease, per Prostate-Specific Antigen Working Group criteria. | 4 weeks | 
| Overall Survival |  | 36 months | 
| Time to Progression | Time from start of treatment until the disease progression per RECIST criteria. | Up to 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate, Androgen, AIPC, Doxil