Erlotinib and SBRT in Treating Patients With Locally Advanced 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: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Stereotactic body radiation therapy may be able to send x-rays
      directly to the tumor and cause less damage to normal tissue. Giving erlotinib together with
      stereotactic body radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving erlotinib together with stereotactic
      body radiation therapy works in treating patients with locally advanced or metastatic
      non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To evaluate the effect of erlotinib and stereotactic body radiotherapy on 6-month
           progression-free survival of patients with locally advanced or metastatic non-small cell
           lung cancer.

      Secondary

        -  To describe the actuarial rate of in-field local control and out-of-field disease
           progression in patients treated with this regimen.

        -  To evaluate the safety of this regimen in these patients.

        -  To evaluate overall survival of patients treated with this regimen.

        -  To evaluate the duration of erlotinib usage and time to initiation of third-line
           systemic therapy (chemotherapy or biologic agent) in these patients.

      OUTLINE: This is a multicenter study.

      Patients receive oral erlotinib hydrochloride once daily in the absence of disease
      progression or unacceptable toxicity. Beginning 1-4 weeks after the initiation of erlotinib
      hydrochloride, patients undergo stereotactic body radiotherapy.

      After completion of study treatment, patients are followed every 3 months.
    

Intervention name(s): Erlotinib; SBRT
Intervention type(s): Drug; Radiation
Intervention description(s): Erlotinib is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen.; SBRT is a treatment method to deliver a high dose of radiation to the target, utilizing either a single dose or a small number of fractions with a high degree of precision within the body
Other intervention name(s): Tarceva; stereotactic body radiation therapy
Intervention MeSH terms: Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Intervention model description: This study is a single arm phase II pilot trial. Patients enrolled on the trial will have been receiving or will begin to receive erlotinib at standard doses (150 mg po per day). SBRT will commence within 4 weeks of the initiation of erlotinib. Maintenance erlotinib will continue until disease progression uncontrollable by SBRT, intolerable toxicity, or death.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; stage IIIA non-small cell lung cancer