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
Intervention: bevacizumab; carboplatin; erlotinib hydrochloride; paclitaxel; gene expression analysis; protein expression analysis; proteomic profiling; laboratory biomarker analysis
Intervention description: 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
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
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

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.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the
             following criteria:

               -  Stage IIIB (with pleural effusion) or stage IV disease

               -  Recurrent disease after prior surgery

          -  Measurable or evaluable disease is desirable but not required

          -  No untreated symptomatic brain metastases

               -  Patients who are neurologically unstable despite radiotherapy for the brain
                  metastases are not eligible

               -  No requirement for steroids to control neurological symptoms

        PATIENT CHARACTERISTICS:

          -  ECOG performance status 0-2

          -  ANC ≥ 1,500/mm³

          -  Hemoglobin ≥ 9 g/dL

          -  Platelet count ≥ 100,000/mm³

          -  Creatinine ≤ 2.0 mg/dL

          -  Total bilirubin ≤ 1.5 mg/dL

          -  Normal hemostasis by history

          -  PT/PTT within 0.5 seconds of normal range

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Willing to undergo biopsy procedures

          -  No known severe hypersensitivity to erlotinib hydrochloride or any of the excipients
             of this product

          -  No other concurrent malignancies or malignancies diagnosed within the past 5 years,
             except basal cell carcinoma or cervical cancer in situ

          -  No significant cardiac disease, including any of the following:

               -  NYHA class III or IV heart disease

               -  Uncontrolled dysrhythmia

               -  Myocardial infarction within the past 6 months

          -  No evidence of clinically active interstitial lung disease

               -  Chronic stable radiographic changes that are asymptomatic allowed

          -  No evidence of any other severe or uncontrolled systemic disease (e.g., unstable or
             uncompensated respiratory, cardiac, hepatic, or renal disease)

          -  No evidence of any other significant clinical disorder or laboratory finding that
             makes it undesirable for the patient to participate in the trial

          -  No uncontrolled hypertension

               -  Blood pressure must be ≤ 150/90 mmHg on a stable antihypertensive regimen

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 6 months since prior adjuvant chemotherapy

          -  No unresolved chronic toxicity > CTC grade 2 from prior anticancer therapy (except
             alopecia)

          -  More than 30 days since prior non-approved or investigational drugs

          -  No prior chemotherapy for advanced NSCLC

          -  No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or St. John's wort

          -  No concurrent administration of other drugs known to inhibit EGFR

          -  No other concurrent anti-neoplastic or anti-tumor agents, including chemotherapy,
             radiotherapy, immunotherapy, or hormonal anticancer therapy

          -  No other concurrent investigational agents

          -  Concurrent cardioprotective doses of aspirin, as recommended by the physician, for
             cardiovascular disease allowed