Study of Erlotinib in Patients With Non-Metastatic Prostate Cancer With a Rising Prostate Specific Antigen (PSA) on Hormone Therapy
NCT00148772 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29
Last updated 2011-06-28
Summary
The primary objective of this study is to evaluate the effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy.
The secondary objectives are to evaluate the effect of erlotinib on the duration of PSA response, to evaluate the effect on the time to PSA progression, to evaluate the toxicity of erlotinib in this patient population, and lastly, to correlate the effect of erlotinib with various epidermal growth factor receptor (EGFR)-related proteins using baseline immunohistochemical (IHC) studies on tissue blocks and peripheral blood mononuclear cells.
Conditions
Interventions
- DRUG
-
Erlotinib (Tarceva)
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY - collaborator OTHER
-
Endeavor Health
lead OTHER
Principal Investigators
-
Daniel Shevrin, MD · Endeavor Health
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2005-08-31
- Primary Completion
- 2008-08-31
- Completion
- 2008-08-31
Countries
- United States
Study Locations
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