Multicenter Phase II Trial of Gefitinib (Iressa™) First Line Therapy Followed by Chemotherapy in Advanced Non-Small Cell Lung Cancer (NSCLC)
- Determine the efficacy of gefitinib as first-line therapy, in terms of response rate
(complete and partial response) or stability of disease, in patients with de novo or
recurrent stage IIIB or IV non-small cell lung cancer.
- Determine the safety of this drug in these patients.
- Determine the efficacy of gemcitabine combined with cisplatin when administered after
first-line gefitinib in these patients.
- Determine quality of life of patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients receive oral gefitinib once daily until disease progression or unacceptable
toxicity. Within 3 weeks after documented disease progression, patients receive gemcitabine
IV over 30 minutes on days 1 and 8 followed by cisplatin IV over 1 hour on day 1. Treatment
repeats every 21 days for 6 courses in the absence of disease progression or unacceptable
Quality of life is assessed at baseline, weeks 3, 6, 12, 18, and then every 12 weeks
thereafter during gefitinib treatment. During chemotherapy, quality of life is assessed 1
week prior to starting chemotherapy treatment, day 1 of courses 3 and 5, and then every 12
weeks until disease progression.
After completion of study therapy, patients are followed every 3 months.
PROJECTED ACCRUAL: `A total of 24-63 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 (complete response [CR], partial response [PR], or stable disease [SD]) after 12 weeks of study treatment
Daniel C. Betticher, MD
University Hospital Inselspital, Berne