Iloprost in Preventing Lung Cancer in Patients at High Risk for This Disease
Condition: Lung Cancer; Precancerous Condition
MeSH terms: Lung Neoplasms; Precancerous Conditions
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
      development or recurrence of cancer. Iloprost may be effective in preventing lung cancer.

      PURPOSE: This randomized phase II trial is studying how well iloprost works in preventing
      lung cancer in patients who are at high risk for this disease.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the reversal of premalignant histological changes in the bronchial epithelium of
           patients at high risk for lung cancer (defined by > 20 pack years of smoking and sputum
           atypia) treated with iloprost vs placebo.

        -  Determine whether this drug modulates Ki-67 proliferation index (Antigen Ki-67) in these
           patients.

        -  Determine whether this drug affects prostaglandin metabolism in these patients.

        -  Determine the toxicity profile of this drug in these patients.

      Secondary

        -  Determine whether this drug modulates a panel of biomarkers, including
           MCM-2(Minichromosome maintenance protein: forms DNA helicase), EGFR (Epidermal growth
           factor receptor: cell surface receptor for the epidermal growth factor family of
           proteins. Mutations in EGFR expression or activity can result in cancer.) , HER2/neu
           (Human epidermal growth factor receptor 2 HER2 is a member of the EGFR family), RARβ
           (Retinoic Acic Receptor Beta is a nuclear transcription regulator and a member of the
           thyroid-steroid hormone receptor superfamily), p53, FHIT (Fragile histidine triad
           protein is an enzyme involved in purine metabolism and had been demonstrated to be a
           tumor suppressor), apoptotic index, and microvessel density, in these patients.

        -  Determine the genes whose expression is altered by this drug in these patients.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are stratified according to smoking status (current vs former) and participating center.
      Patients are randomized to 1 of 2 treatment arms.

        -  Arm I: Patients receive oral iloprost twice daily.

        -  Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues for
           6 months in the absence of unacceptable toxicity.

      Patients are followed at 1 month and then annually thereafter.

      PROJECTED ACCRUAL: A total of 152 patients (76 [38 current smokers and 38 former smokers] per
      treatment arm) will be accrued for this study within 2 years.
    

Intervention name(s): iloprost; placebo
Intervention type(s): Drug; Other
Intervention description(s): Given orally; Given orally
Intervention MeSH terms: Iloprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: non-small cell lung cancer; squamous lung dysplasia