Erlotinib, Paclitaxel, and Carboplatin in Treating Patients With Stage III, Stage IV, or Recurrent Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Carboplatin; erlotinib hydrochloride; Paclitaxel; erlotinib hydrochloride
Intervention description: 150mg; 200mg/m2; 1500mg
Intervention MeSH terms: Paclitaxel; Carboplatin; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer

Summary:

      RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work
      in different ways to stop the growth of tumor cells, either by killing the cells or by
      stopping them from dividing. Giving erlotinib together with paclitaxel and carboplatin may
      kill more tumor cells.

      PURPOSE: This randomized phase II trial is studying two different doses of erlotinib when
      given together with paclitaxel and carboplatin to compare how well they work in treating
      patients with stage III, stage IV, or recurrent non-small cell lung cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Pathologically confirmed non-small cell lung cancer

               -  Stage IIIB or IV or recurrent disease

          -  Measurable or evaluable indicator lesions

          -  Must have smoked ≥ 100 cigarettes in his/her lifetime

        PATIENT CHARACTERISTICS:

          -  Karnofsky performance status 70-100%

          -  WBC ≥ 4,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Creatinine ≤ 1.5 mg/dL OR creatinine clearance ≥ 50 mL/min

          -  Bilirubin ≤ 1.0 mg/dL

          -  AST ≤ 2.5 times upper limit of normal (ULN)

          -  Alkaline phosphatase ≤ 2.5 times ULN

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 1 week after
             completion of study treatment

          -  No gastrointestinal tract disease or inability to take oral medication

          -  No prior malignancy within the past 2 years except nonmelanoma skin cancer or
             carcinoma in situ of the cervix

          -  No other active medical problems, including severe infection, unstable angina, or
             myocardial infarction within the past 6 months

          -  No poorly controlled hypertension or severe malnutrition

          -  No New York Heart Association class III or IV congestive heart failure or serious
             cardiac arrhythmia requiring medication except chronic atrial arrhythmia (i.e., atrial
             fibrillation or paroxysmal supraventricular tachycardia)

        PRIOR CONCURRENT THERAPY:

          -  At least 3 weeks since prior radiotherapy to major bone marrow-containing sites

          -  No prior chemotherapy for advanced non-small cell lung cancer

          -  No prior agents directed at the epidermal growth factor receptor (EGFR)/HER axis
             (e.g., gefitinib, cetuximab, or trastuzumab [Herceptin®])

          -  No prior surgical procedure resulting in abnormal absorption of oral medications

          -  No concurrent surgical resection, palliative radiotherapy, or hormonal therapy

          -  No other concurrent anticancer therapy