Proteomic Profiling in Predicting Response in Patients Receiving Erlotinib for Stage IIIB, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): bevacizumab; carboplatin; erlotinib hydrochloride; paclitaxel; gene expression analysis; protein expression analysis; proteomic profiling; laboratory biomarker analysis
Intervention type(s): Drug; Drug; Drug; Drug; Genetic; Genetic; Genetic; Other
Intervention description(s): 15 mg/m2 given through a vein for every 3 weeks; AUC = 6 given through a vein on day 1 of each cycle.; 150 mg taken by mouth daily; 200 mg/m2 given through a vein on day 1 of each cycle.; Blood and tissue collection.; Blood and tissue collection.; Blood and tissue collection.; Blood and tissue collection.
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin; Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer; squamous cell lung cancer; adenosquamous cell lung cancer; bronchoalveolar cell lung cancer; large cell lung cancer; adenocarcinoma of the lung