Study of Erlotinib in Patients With Non-Metastatic Prostate Cancer With a Rising Prostate Specific Antigen (PSA) on Hormone Therapy

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Endeavor Health
Study ID
NCT00148772
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

First listed
Sep 8, 2005
Start date
Aug 31, 2005
Status verified
Aug 2005
Primary completion
Aug 31, 2008
Completion
Aug 31, 2008

Study Design

Enrollment
29 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Primary Outcome Measure

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

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-
Evanston Northwestern HealthcareEvanstonIllinois60201-

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