Paclitaxel/Carboplatin (PC) Followed by Gefitinib or Paclitaxel/Carboplatin (PC) in Advanced Non-small Cell Lung Cancer (NSCLC): Randomized Phase II Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Response Rate
研究概览
简要总结
This study compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with Non-small Cell Lung Cancer (NSCLC) without epidermal growth factor receptor (EGFR) mutations.
Expanded acronym : [P]aclitaxel/Ca[r]boplatin (PC) followed by Gef[i]tinib in A[d]vanc[e]d Non-small Cell Lung Cancer (NSCLC): Randomized phase II study.
详细描述
A randomized phase II trial that compares paclitaxel/carboplatin (PC) to PC chemotherapy followed by gefitinib for 2 weeks in patients with NSCLC without EGFR mutations. While previous studies with cytotoxic agents and gefitinib failed to show any benefit, we altered the schedule of administration in hopes to gain synergy between agents.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •More than 18 years of age
- •Histologically documented non-small cell lung cancer with metastasis (Stage IV) or locally advanced (Stage IIIB) with malignant effusion.
- •At least 1 measurable lesion as defined by RECIST1.
- •All target lesions must have a unidirectional diameter of at least 1cm. Baseline measurements must be compared within 4 weeks prior to enrollment.
- •ECOG PS 0-2
- •At least 1 week since the last radiotherapy. Patients must have recovered from all acute toxicities from radiotherapy.
- •Patients must have adequate hematologic, renal and liver function as defined by Hb > 9g/dL, neutrophils > 1000/mm3, platelets > 50,000/mm3, creatinine < 2mg/dL, and AST (SGOT) and/or ALT (SGPT) < 5 x UNL (upper normal limit).
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures.
- •Written and voluntary informed consent understood, signed and dated.
排除标准
- •Patients with tumor harboring EGFR mutation.
- •Prior systemic therapy for NSCLC
- •Non-smoking patients with adenocarcinoma. But if those patients show wild type EGFR, they are eligible to this study.
- •Symptomatic brain metastasis. Brain metastases stable < 2 weeks before dosing or requiring concurrent steroid treatment or with clinical symptoms.
- •Major surgery within 3 weeks prior to study enrollment.
- •Previous (less than 3 years ago) or current malignancies at sites other than curatively treated in situ carcinoma of cervix, or basal or squamous cell carcinoma of the skin.
- •Severe medical illness or active infection that would impair the ability to receive gefitinib.
- •Pregnancy or breast feeding.
研究组 & 干预措施
Paclitaxel/Carboplatin/Gefitinib
Paclitaxel/Carboplatin/Gefitinib
干预措施: Paclitaxel/Carboplatin/Gefitinib (Drug)
Paclitaxel/Carboplatin
Paclitaxel/Carboplatin
干预措施: Paclitaxel/Carboplatin (Drug)
结局指标
主要结局
Response Rate
时间窗: average 6 months
次要结局
- progression free survival(average 2 years)
- overall survival(average 2 years)
研究者
Sang-We Kim
Professor
Asan Medical Center