A Pilot (Phase I) Study of Weekly Docetaxel and Cetuximab Chemoradiation for Poor Risk Stage III Non-Small Cell Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 24
- 试验地点
- 76
- 主要终点
- Treatment-related Esophagitis or Pneumonitis
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving docetaxel and cetuximab together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of docetaxel when given together with cetuximab and radiation therapy in treating patients with stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- Test the feasibility and toxicity of combined cetuximab, weekly docetaxel, and concurrent radiotherapy in patients with poor-risk stage III non-small cell lung cancer (NSCLC).
Secondary
- Evaluate response rates (confirmed and unconfirmed, complete and partial) as well as overall and progression-free survival.
- Correlate EGFR mutations, KRAS mutations, EGFR/HER2 gene copy number detected by FISH, and protein expression by immunohistochemistry of EGFR-HER signaling pathways, phosphorylation, proliferative markers, apoptotic markers, selected oncogene markers, and markers for angiogenesis in biopsied pre-treatment tumor tissues with response and survival outcomes.
- Explore possible associations between changes in plasma angiogenic factors (VEGF, IL-8, bFGF) and cytokine levels (IL-6, IL-1α, ICAM, TGF-β, and others) and the risk of treatment-related pneumonitis and esophagitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
Cetuximab + Radiotherapy (no Docetaxel)
干预措施: cetuximab (Biological)
Cetuximab + Radiotherapy (no Docetaxel)
干预措施: radiation therapy (Radiation)
Cetuximab + Radiotherapy + Docetaxel
干预措施: cetuximab (Biological)
Cetuximab + Radiotherapy + Docetaxel
干预措施: docetaxel (Drug)
Cetuximab + Radiotherapy + Docetaxel
干预措施: radiation therapy (Radiation)
结局指标
主要结局
Treatment-related Esophagitis or Pneumonitis
时间窗: Weekly for the first 8 weeks, then every 4 weeks thereafter for up to 4 months after complettion of radiotherapy.
The primary endpoint will be the rate of Grade 3 or greater esophagitis and/or pneumonitis within 4 months after discontinuation of radiation therapy.
次要结局
- Toxicity(Weekly for the first 8 weeks, then every 4 weeks while subject on protocol treatment.)
- Overall Survival(weekly while patient is on protocol treatment, then monthly thereafter.)
- Progression-free Survival.(At week 10, week 22, and then every 3 months until progression for up to 3 years after enrollment.)
- Response Rate(Week 10 and week 22)