A Phase I/II Trial of Neoadjuvant Paclitaxel, Carboplatin and OSI-774 (Tarceva) With Concurrent Accelerated Hyperfractionation Radiation Followed by Maintenance Therapy With OSI-774 for Stage III Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Tolerability of Long-term OSI-774 (Phase II)
研究概览
简要总结
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving erlotinib, paclitaxel, and carboplatin together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase I/II trial is studying the best dose of erlotinib and the side effects of erlotinib, paclitaxel, and carboplatin when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Assess the safety and feasibility of erlotinib hydrochloride, paclitaxel, and carboplatin in combination with accelerated hyperfractionated radiotherapy in patients with stage IIIA or IIIB non-small cell lung cancer.
- Determine the maximum tolerated dose and recommended phase II dose of erlotinib hydrochloride in these patients.
- Assess the safety and tolerability of long-term maintenance erlotinib hydrochloride after completion of adjuvant chemoradiotherapy in these patients.
Secondary
- Evaluate the clinical and pathological response rate in these patients after neoadjuvant erlotinib hydrochloride, paclitaxel, carboplatin, and radiotherapy.
- Assess the impact of erlotinib hydrochloride on disease-free survival, overall survival, locoregional control, and distant metastatic control in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Dose Level A
Erlotinib, Paclitaxel, and Carboplatin with Radiation
Dose Level A: 50 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
干预措施: conventional surgery (Procedure)
Dose Level A
Erlotinib, Paclitaxel, and Carboplatin with Radiation
Dose Level A: 50 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
干预措施: carboplatin (Drug)
Dose Level A
Erlotinib, Paclitaxel, and Carboplatin with Radiation
Dose Level A: 50 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
干预措施: Erlotinib (Drug)
Dose Level A
Erlotinib, Paclitaxel, and Carboplatin with Radiation
Dose Level A: 50 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
干预措施: paclitaxel (Drug)
Dose Level A
Erlotinib, Paclitaxel, and Carboplatin with Radiation
Dose Level A: 50 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
干预措施: radiation therapy (Radiation)
Dose Level B
Erlotinib, Paclitaxel, and Carboplatin with Radiation
Dose Level B: 100 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
干预措施: carboplatin (Drug)
Dose Level B
Erlotinib, Paclitaxel, and Carboplatin with Radiation
Dose Level B: 100 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
干预措施: Erlotinib (Drug)
Dose Level B
Erlotinib, Paclitaxel, and Carboplatin with Radiation
Dose Level B: 100 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
干预措施: paclitaxel (Drug)
Dose Level B
Erlotinib, Paclitaxel, and Carboplatin with Radiation
Dose Level B: 100 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
干预措施: conventional surgery (Procedure)
Dose Level B
Erlotinib, Paclitaxel, and Carboplatin with Radiation
Dose Level B: 100 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
干预措施: radiation therapy (Radiation)
Dose Level C
Erlotinib, Paclitaxel, and Carboplatin with Radiation
Dose Level C: 150 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
干预措施: carboplatin (Drug)
Dose Level C
Erlotinib, Paclitaxel, and Carboplatin with Radiation
Dose Level C: 150 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
干预措施: Erlotinib (Drug)
Dose Level C
Erlotinib, Paclitaxel, and Carboplatin with Radiation
Dose Level C: 150 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
干预措施: paclitaxel (Drug)
Dose Level C
Erlotinib, Paclitaxel, and Carboplatin with Radiation
Dose Level C: 150 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
干预措施: conventional surgery (Procedure)
Dose Level C
Erlotinib, Paclitaxel, and Carboplatin with Radiation
Dose Level C: 150 mg OSI-774/50 mg/m2 Paclitaxel/2 AUC Carboplatin
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Tolerability of Long-term OSI-774 (Phase II)
时间窗: 2 years
Number of patients who experienced grade \>/= 3 toxicities on maintanance erolotinib (OSI-774)
Maximum Tolerated Dose of Erlotinib Hydrochloride (Phase I)
时间窗: 2 weeks after surgery
The Phase I portion of this study is to determine the Maximum Tolerated Dose (MTD) of combining OSI-774 with the paclitaxel-carboplatin chemoradiation protocol and to assess the safety and feasiblity of this combination.
次要结局
- Pathological Complete Response Rate(2 years)
- Progression Free Survival (PFS)(3 years)
- Locoregional Control(2 years)
- Overall Survival(3 years)
- Distant Control(2 years)
研究者
Nathan Pennell, MD, PhD
Principal Investigator
Case Comprehensive Cancer Center