Gefitinib, Docetaxel, and Radiation Therapy in Treating Patients With Stage III Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways
      to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gefitinib
      together with docetaxel and radiation therapy may kill more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when
      given together with gefitinib and radiation therapy in treating patients with stage III
      non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of docetaxel that can be safely delivered in
           combination with gefitinib and a definitive course of 3-D planned thoracic radiotherapy
           in patients with stage III non-small cell lung cancer.

      OUTLINE: This is a dose-escalation study of docetaxel.

        -  Chemoradiotherapy: Patients receive concurrent chemoradiotherapy comprising docetaxel IV
           over 30 minutes on day 1 and thoracic radiotherapy once daily on days 1-5 in weeks 1-7
           in the absence of disease progression or unacceptable toxicity.

        -  Consolidation chemotherapy: Beginning 2 weeks after the completion of chemoradiotherapy,
           patients receive consolidation chemotherapy comprising docetaxel IV over 60 minutes on
           days 1 and 22.

        -  Gefitinib therapy: Patients also receive oral gefitinib once daily beginning at the
           start of chemoradiotherapy and continuing for up to 1 year* in the absence of disease
           progression.

      NOTE: *Patients continue to receive gefitinib during the 2-week rest period between
      chemoradiotherapy and consolidation chemotherapy.

      Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2
      of 6 patients experience dose-limiting toxicity.

      Tumor tissue is tested to determine correlation between epidermal growth factor receptor
      presence and response to treatment.

      After completion of study treatment, patients are followed every 3 months for 2 years and
      then every 6 months for 3 years.

      PROJECTED ACCRUAL: A total of 45 patients will be accrued in this study.
    

Intervention name(s): docetaxel; gefitinib; laboratory biomarker analysis; radiation therapy
Intervention type(s): Drug; Drug; Other; Radiation
Intervention MeSH terms: Docetaxel; Gefitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer; adenosquamous cell lung cancer; bronchoalveolar cell lung cancer; large cell lung cancer; squamous cell lung cancer; adenocarcinoma of the lung