Bevacizumab and Erlotinib First-Line Therapy in Advanced Non-Squamous Non-Small-Cell Lung Cancer (Stage IIIB/IV) Followed by Platinum-Based Chemotherapy at Disease Progression. A Multicenter Phase II Trial
- 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).
- Assess the safety of bevacizumab and erlotinib hydrochloride as initial therapy in
- Assess the quality of life (QOL) in patients treated with bevacizumab and erlotinib
- 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.
- 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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease stabilization (DS) (complete response [CR], partial response [PR], or stable disease [SD]) as assessed by RECIST criteria after 12 weeks of treatment with bevacizumab and erlotinib hydrochloride
Francesco Zappa, MD
Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni