Prostate Cancer Clinical Trial
Official title:
Phase II Study Investigating the Efficacy and Activity of Single Agent Erlotinib in Chemotherapy-Naive Androgen Independent Prostate Cancer
Objectives to evaluate the activity of Erlotinib in prostate cancer patients who are hormone refractory and androgen independent and have not been exposed to chemotherapy.
This is a phase II open label single center study that evaluates the activity, efficacy, and
toxicity of single agent Tarceva in chemotherapy-naive AIPC patients. Patients will receive
single agent Tarceva at 150 mg daily without interruption until disease progression,
unacceptable toxicity, or investigator's discretion. Eligible patients are those with
documented prostate cancer (regardless of Gleason Score) who are considered hormone
refractory as defined below. All patients must fail an anti-androgen withdrawal trial if they
were already on such therapy. If patients were on LHRH analogues alone, they must fail the
addition of an anti-androgen before being classified as hormone refractory. All patients must
have adequate organ functions as specified below and have an ECOG performance status of 2 or
less. It is hypothesized that 25 patients will be needed to adequately assess the activity of
Tarceva in AIPC.
The activity of Tarceva in other malignancies has been demonstrated with dosed ranging from
100 to 150 mg daily. It is acceptable not to interrupt therapy unless toxicity occurs of
disease progression is documented. Starting patients at 150 mg daily seems to be the most
logical step, but dose reductions will be implemented based on side effects and adverse
events.
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