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

University of Pittsburgh

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Thalidomide

Drug: Doxil

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00307294

05-078

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.