A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients - A Phase II Study of Erlotinib for previously treated Non-Small Cell Lung Cancer Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
研究概览
简要总结
9th JSMO annual meeting 2011 [Purpose] To evaluate the efficacy and safety of erlotinib in patients with previously treated non-small cell lung cancer (NSCLC), a phase II trial was studied in Kochi prefecture.[Patients and methods] Patients with stage IIIB/IV NSCLC and performance status 2 or lower, previously treated with 1 or 2 non- EGFR-TKI regimens were eligible. The enrollment has started since august 2009. Patients received Erlotinib (150mg/day) until disease progression or intolerable toxicity. Primary end point was the response rate (RR). In addition, disease control rate (DCR), progression free survival (PFS), and safety were evaluated.[Results] Thirty eight patients were enrolled, and 32 patients were evaluated. Median age was 69 years (range, 57 years to 80 years). Characteristics of patients were as follows: men/women, 21/11; PS0/1/2, 11/16/5; adenocarcinoma/ non-adenocarcinoma, 23/9. The objective RR and DCR were 31% and 65%, respectively. Twenty one patients could be evaluated for EGFR status (9 mutated/ 11 wild type). The RR of EGFR mutated patients was 67%, while wild type 17%. PFS of 24 cases were evaluated as 117 days. Major adverse events were tolerable skin toxicities, diarrhea, and stomatitis.[Conclusion] Erlotinib was efficacious in patients with previously treated NSCLC. Efficacy and safety were similar to previous reports.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) Patients with active lung disease such as interstitial pneumonia, pneumoconiosis, active radiation pneumonitis,or drug-induced pneumonitis 2) Patients with massive pleural or pericardial effusion,or ascites 3) Patients with active severe infections 4) Cases with past history of administration of HER related agents 5) Impossible cases with oral administration 6) Patients with active opthalmological disease 7) Pregnancy or lactation 8) Patients with symptomatic brain metastasis 9) Patients with active concomitant malignancy 10) Patients with uncontrollabe diabetes mellitus 11) Patients with uncontrollable complications 12) Inappropriate patients for this study judged by the physicians