Carboplatin and Gemcitabine Combined With Celecoxib and/or Zileuton in Treating Patients With Advanced 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: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different
      ways to stop tumor cells from dividing so they stop growing or die. Celecoxib and zileuton
      may stop the growth of tumor cells by stopping blood flow to the tumor and may block the
      enzymes necessary for tumor cell growth. Combining chemotherapy with celecoxib and/or
      zileuton may kill more tumor cells.

      PURPOSE: Randomized phase II trial to study the effectiveness of combining celecoxib and/or
      zileuton with carboplatin and gemcitabine in treating patients who have advanced non-small
      cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the efficacy of carboplatin and gemcitabine with celecoxib and/or zileuton, in
           terms of 7-month progression-free survival, in patients with advanced non-small cell
           lung cancer.

      Secondary

        -  Compare the response rate, distribution of survival, and failure-free survival time of
           patients treated with these regimens.

        -  Correlate CYFRA and serum vascular endothelial growth factor levels with response and
           survival of patients treated with these regimens.

        -  Correlate cyclo-oxygenase-2 and 5-lipoxygenase expression with survival of patients
           treated with these regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment
      arms.

        -  Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8, carboplatin IV
           over 30 minutes on day 1, and oral zileuton 4 times daily on days 1-21.

        -  Arm II: Patients receive gemcitabine and carboplatin as in arm I and oral celecoxib
           twice daily on days 1-21.

        -  Arm III: Patients receive gemcitabine and carboplatin as in arm I, oral celecoxib as in
           arm II, and oral zileuton as in arm I.

      In all arms, treatment repeats every 21 days for 6 courses. Patients with responding or
      stable disease continue courses of zileuton and/or celecoxib in the absence of disease
      progression or unacceptable toxicity.

      Patients are followed monthly for 1 year, every 2 months for 2 years, and then every 4 months
      for 3 years or until disease progression.

      PROJECTED ACCRUAL: A total of 117 patients (39 per treatment arm) will be accrued for this
      study within 11-12 months.
    

Intervention name(s): carboplatin; celecoxib; gemcitabine hydrochloride; zileuton
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): given IV; given PO; given IV; given PO
Intervention MeSH terms: Celecoxib; Zileuton; Carboplatin; Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV non-small cell lung cancer; adenocarcinoma of the lung; squamous cell lung cancer; large cell lung cancer; stage IIIB non-small cell lung cancer