Bevacizumab and Erlotinib Followed by Cisplatin or Carboplatin and Gemcitabine in Treating Patients With Newly Diagnosed or Recurrent Stage IIIB or Stage IV NSCLC
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the
      growth of tumor cells by blocking blood flow to the tumor. Erlotinib may stop the growth of
      tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in
      chemotherapy, such as cisplatin, carboplatin, and gemcitabine, work in different ways to stop
      the growth of tumor cells, either by killing the cells or by stopping them from dividing.
      Giving bevacizumab together with erlotinib followed by cisplatin or carboplatin and
      gemcitabine at disease progression may be an effective treatment for non-small cell lung
      cancer.

      PURPOSE: This phase II trial is studying how well giving bevacizumab together with erlotinib
      followed by cisplatin or carboplatin and gemcitabine works in treating patients with newly
      diagnosed or recurrent stage IIIB or stage IV non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Assess the efficacy of bevacizumab and erlotinib hydrochloride as initial therapy in
           patients with newly diagnosed or recurrent stage IIIB or IV non-squamous non-small cell
           lung cancer (NSCLC).

      Secondary

        -  Assess the safety of bevacizumab and erlotinib hydrochloride as initial therapy in these
           patients.

        -  Assess the quality of life (QOL) in patients treated with bevacizumab and erlotinib
           hydrochloride.

        -  Assess the efficacy and safety of subsequent cisplatin or carboplatin in combination
           with gemcitabine hydrochloride in patients who have disease progression.

        -  Assess the QOL in patients treated with subsequent cisplatin or carboplatin in
           combination with gemcitabine hydrochloride at disease progression.

      Tertiary

        -  Identify novel biomarkers in predicting response to therapy and toxicity in patients
           treated with bevacizumab and erlotinib hydrochloride as initial therapy.

      OUTLINE: This is a multicenter, prospective, open-label study.

      Patients receive bevacizumab IV over 90 minutes on day 1 and oral erlotinib hydrochloride
      once daily on days 1-21. Treatment repeats every 3 weeks in the absence of disease
      progression or unacceptable toxicity.

      Beginning within 3 weeks of documented disease progression, patients receive gemcitabine
      hydrochloride IV over 30 minutes on days 1 and 8. They also receive cisplatin IV over 1 hour
      or carboplatin IV over 30 minutes on day 1. Treatment with gemcitabine hydrochloride with
      either cisplatin or carboplatin repeats every 21 days for up to 6 courses in the absence of
      disease progression or unacceptable toxicity.

      Quality of life is assessed at baseline and periodically during study treatment.

      After completion of study treatment, patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 101 patients will be accrued for this study.
    

Intervention name(s): bevacizumab + erlotinib hydrochloride; gemcitabine hydrochloride + cisplatin or carboplatin
Intervention type(s): Drug; Drug
Intervention description(s): Patients receive bevacizumab IV over 90 minutes on day 1 and oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.; Beginning within 3 weeks of documented disease progression, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. They also receive cisplatin IV over 1 hour or carboplatin IV over 30 minutes on day 1. Treatment with gemcitabine hydrochloride with either cisplatin or carboplatin repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Intervention MeSH terms: Bevacizumab; Carboplatin; Gemcitabine; Erlotinib Hydrochloride
Intervention model: Single Group Assignment
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; adenocarcinoma of the lung; bronchoalveolar cell lung cancer; large cell lung cancer