Paclitaxel/Carboplatin Combined With Intermittent Gefitinib in Patients With Untreated Advanced Non-small Cell Lung Cancer: A Phase Ⅱa Trial
- To determine the efficacy, in terms of overall response, and safety of paclitaxel and
carboplatin in combination with intermittent gefitinib in patients with advanced
nonsquamous non-small cell lung cancer.
- Determine the disease-control rate in patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
- Determine the progression-free and overall survival of patients treated with this
OUTLINE: Patients receive paclitaxel IV on day 1, carboplatin IV on day 2, and oral
gefitinib once daily on days 8-17. Treatment repeats every 21 days for 4 courses in the
absence of disease progression or unacceptable toxicity. After completion of 4 courses,
patients with complete response or partial response may continue maintenance therapy
comprising oral gefitinib once daily in the absence of disease progression or unacceptable
Patients complete the Functional Assessment of Cancer Therapy-Lung (FACT-L) at baseline,
during study treatment, and after completion of study treatment for quality-of-life study.
After completion of study treatment, patients are followed every 2 months for 2 years and
then every 4 months thereafter.
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Yuankai Shi, MD, PhD
Cancer Institute Hospital, Chinese Academy of Medical Sciences