Phase II Study Investigating the Efficacy and Activity of Single Agent Erlotinib in Chemotherapy-Naive Androgen Independent Prostate Cancer
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate the overall clinical benefit of Tarcev in AIPC
during study
No
Chadi Nabhan, MD
Principal Investigator
Oncology Specialists, SC
United States: Institutional Review Board
OSI3652S (0513)
NCT00272038
December 2005
October 2010
Name | Location |
---|---|
Oncology Specialists, SC | Park Ridge, Illinois 60068 |