Spots Global Cancer Trial Database for Proteomic Profiling in Predicting Response in Patients Receiving Erlotinib for Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Proteomic Profiling in Predicting Response in Patients Receiving Erlotinib for Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Official Title: A Feasibility Study Investigating Translational Science in Chemotherapy-Naive Patients With Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC) Treated With the EGFR-TKI, Erlotinib
Study ID: NCT00550537
Conditions
Study Description
Brief Summary: RATIONALE: Studying samples of tumor tissue, blood, and urine in the laboratory from patients receiving erlotinib may help doctors predict how patients will respond to treatment. PURPOSE: The phase II trial is studying proteomic profiling to see how well it predicts response in patients receiving erlotinib for stage IIIB, stage IV, or recurrent non-small cell lung cancer.
Detailed Description: OBJECTIVES: Primary * To define a pre-treatment tumor proteomic profile that predicts response, stable disease, or progressive disease in patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer treated with erlotinib hydrochloride. Secondary * To test and refine a pre-treatment serum proteomic expression pattern that predicts response to erlotinib hydrochloride and/or carboplatin and paclitaxel after failing treatment with erlotinib hydrochloride. * To test and refine tumor proteomic profiles that predict response to carboplatin and paclitaxel after failing treatment with erlotinib hydrochloride. * To analyze individual and pattern(s) of erlotinib hydrochloride-induced genomic and proteomic biomarker changes in relation to response or non-response to treatment. * To correlate the efficacy and toxicity of erlotinib hydrochloride with expression of EGFR, EGFR pathway, ErbB family, and other related biomarkers. * To determine a set of biomarkers to be evaluated in tumor tissue or surrogate tissues prior to treatment with erlotinib hydrochloride to enable patient selection for therapy. * To estimate response rate and progression-free and overall survival of patients treated with erlotinib hydrochloride as initial therapy. * To characterize the safety profile of erlotinib hydrochloride in these patients. OUTLINE: This is a multicenter study. Patients receive oral erlotinib hydrochloride once daily until disease progression. At the time of disease progression, patients receive standard chemotherapy comprising paclitaxel IV over 3 hours and carboplatin IV over 15-30 minutes on day 1. Patients with non-squamous cell non-small cell lung cancer also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses. Tumor tissue, plasma, serum, and urine samples are collected at baseline for proteomics analysis. After the completion of study treatment, patients are followed every 8 weeks.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Florida Shands Cancer Center, Gainesville, Florida, United States
Emory University, Atlanta, Georgia, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Vanderbilt-Ingram Cancer Center - Cool Springs, Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Franklin, Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
M. D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
Contact Details
Name: David Carbone, M.D., Ph.D.
Affiliation: Vanderbilt-Ingram Cancer Center
Role: STUDY_CHAIR
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