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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study Investigating the Efficacy and Activity of Single Agent Erlotinib in Chemotherapy-Naive Androgen Independent Prostate Cancer|
- Overall Clinical Benefit of Tarceva in CRPC. [ Time Frame: 5 years ] [ Designated as safety issue: No ]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 to Disease Progression (TTP) [ Time Frame: five years ] [ Designated as safety issue: No ]Progression is defined using response evaluation criteria in solid tumors criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a meausrable increase in a non-target lesion, or the appearance of new lesions or the appearance of two new bone lesions.
- Overall Survival [ Time Frame: during study ] [ Designated as safety issue: No ]One year survival rate.
- Toxicity [ Time Frame: during study ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2005|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Tarceva 150 mg QD
Other Name: erlotinib
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.
|United States, Illinois|
|Oncology Specialists, SC|
|Park Ridge, Illinois, United States, 60068|
|Principal Investigator:||Chadi Nabhan, MD||Oncology Specialists, SC|