NCT00550537

Proteomic Profiling in Predicting Response in Patients Receiving Erlotinib for Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	bevacizumab	15 mg/m2 given through a vein for every 3 weeks
DRUG	carboplatin	AUC = 6 given through a vein on day 1 of each cycle.
DRUG	erlotinib hydrochloride	150 mg taken by mouth daily
DRUG	paclitaxel	200 mg/m2 given through a vein on day 1 of each cycle.
GENETIC	gene expression analysis	Blood and tissue collection.
GENETIC	protein expression analysis	Blood and tissue collection.
GENETIC	proteomic profiling	Blood and tissue collection.
OTHER	laboratory biomarker analysis	Blood and tissue collection.

Timeline

• Start date: 2007-10-01
• Primary completion: 2011-09-01
• Completion: 2013-12-01
• First posted: 2007-10-30
• Last updated: 2017-06-08
• Results posted: 2017-04-25

Locations

7 sites across 1 country: United States