Gefitinib With or Without Carboplatin and Paclitaxel in Treating Older Patients With Unresectable or Metastatic 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: Biological therapies such as gefitinib may interfere with the growth of cancer
      cells and slow the growth of the tumor. Drugs used in chemotherapy such as carboplatin and
      paclitaxel use different ways to stop tumor cells from dividing so they stop growing or die.
      Combining gefitinib with carboplatin and paclitaxel may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gefitinib alone or together with
      carboplatin and paclitaxel works in treating older patients with unresectable or metastatic
      non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the 6-month progression status of older patients with unresectable or
           metastatic non-small cell lung cancer treated with gefitinib alone or with carboplatin
           and paclitaxel.

      Secondary

        -  Determine the response rate in patients treated with these regimens.

        -  Determine the quality of life of patients treated with these regimens.

        -  Determine whether serum-secreted or soluble epidermal growth factor receptor (EGFR)
           concentrations predict response in patients treated with these regimens.

        -  Correlate the presence of social support for these patients with toxicity and efficacy
           of these regimens.

        -  Determine whether social support for these patients differs according to gender.

        -  Determine the reasons an oncologist would choose a chemotherapy vs a nonchemotherapy
           regimen for these patients.

      Tertiary

        -  Correlate EGFR signaling pathway markers, RNA expression profile, gene polymorphisms of
           prespecified germline and tumor genes, and plasma and urine proteomic patterns with
           response rate and time to progression of patients receiving treatment in group I.

      OUTLINE: This is a nonrandomized, multicenter study. Patients are assigned to 1 of 2
      treatment groups as determined by their treating physician.

        -  Group I: Patients receive oral gefitinib on days 1-28. Courses repeat every 28 days in
           the absence of disease progression or unacceptable toxicity.

        -  Group II: Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes
           on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence
           of disease progression or unacceptable toxicity. After completion of chemotherapy and in
           the absence of disease progression, patients receive oral gefitinib as in group I.

      Quality of life is assessed at baseline and after the completion of course 2.

      Patients are followed every 3 months for 5 years.

      PROJECTED ACCRUAL: A total of 107 patients (51 for group I and 56 for group II) will be
      accrued for this study within 1.7 years.
    

Intervention name(s): carboplatin; gefitinib; paclitaxel
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Paclitaxel; Carboplatin; Gefitinib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV non-small cell lung cancer; stage IIIB non-small cell lung cancer