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

No results posted yet for this study

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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00148772 on ClinicalTrials.gov