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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
150mg QD
Oncology Specialists, SC
Park Ridge, Illinois, United States
Overall Clinical Benefit of Tarceva in CRPC.
Overall Clinical Benefit = percentage of partial responders (PR)+ the percentage of patients with stable disease (SD). Partial Response (PR) is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum. Stable Disease (SD)is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for Progressive Disease, using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0).
Time frame: 5 years
Overall Survival
One year survival rate.
Time frame: during study
Time to Disease Progression
Patients were evaluated for response biochemically and radiographically at each response assessment. RECIST 1.0 criteria were used for radiographic response. PSA measurement at a central laboratory was used to assess biochemical response. Patients must have had a baseline PSA of 5 ng/ml to be evaluated for PSA response. PSA was measured every 8 weeks. For patients with measurable disease radiographically, PSA progression was not considered as having progressive disease. Refer to study publication for details.
Time frame: 25 months
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