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

Completed · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00307294

Run by

University of Pittsburgh

People needed

40

Starts

2006-03-01

Expected to finish

2012-01-01

Last updated by the study team

2017-11-24

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients with unstable angina, uncompensated CHF, a history of an MI, PE or DVT within the last 3 months

Where it is running

• Hillman Cancer Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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