Phase I Study of Oxaliplatin in Combination With Docetaxel and Radiotherapy in Patients With Unresectable or Recurrent Non-Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose of oxaliplatin in combination with docetaxel and radiotherapy
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and docetaxel, 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. Oxaliplatin and docetaxel may make tumor cells more sensitive to radiation therapy. Giving oxaliplatin and docetaxel together with radiation therapy may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of oxaliplatin when given together with docetaxel and radiation therapy in treating patients with unresectable stage II or stage III or recurrent non-small cell lung cancer .
详细描述
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of oxaliplatin when given with docetaxel and thoracic radiotherapy in patients with unresectable stage II, IIIA, or IIIB or recurrent non-small cell lung cancer.
Secondary
- Determine the dose-limiting toxicities of this regimen in these patients.
- Determine the objective tumor response in patients treated with this regimen.
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
- •Diagnosis of non-small cell lung cancer (NSCLC) meeting 1 of the following criteria:
- •Medically inoperable or unresectable stage II, IIIA, or IIIB disease
- •Post-resection intrathoracic tumor recurrence
- •Measurable disease by computed tomography(CT) scan
- •No evidence of small cell histology
- •No significant pleural effusion on chest x-ray or malignant pleural effusion on cytology
- •No metastatic disease
- •Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1
- •Absolute granulocyte count ≥ 2,000/mm³
- •Platelet count ≥ 100,000/mm³
- •Hemoglobin ≥ 8.0 g/dL
- •Bilirubin ≤ 1.5 mg/dL
- •Serum glutamic oxaloacetic transaminase (SGOT) ≤ 1.5 times upper limit of normal (unless abnormality is caused by documented benign disease)
- •Creatinine ≤ 1.5 mg/dL
- •Weight loss ≤ 10% within the past 3 months
- •Forced expiratory volume (FEV) 1 ≥ 1,000 cc
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after completion of study treatment
排除标准
- •Synchronous (except for nonmelanomatous skin cancer) or prior invasive malignancy, unless disease free for > 3 years
- •Myocardial infarction within the past 6 months
- •Symptomatic heart disease, including any of the following:
- •Congestive heart failure
- •Uncontrolled arrhythmia
- •Active infection or fever ≥ 38.5°C within the past 3 days
- •Known hypersensitivity to any of the components of oxaliplatin or docetaxel
- •Prior thoracic or neck radiotherapy
- •Prior docetaxel or oxaliplatin
研究组 & 干预措施
Chemoradiation Treated Patients
Patients receiving Docetaxel, Oxaliplatin and radiotherapy.
干预措施: docetaxel (Drug)
Chemoradiation Treated Patients
Patients receiving Docetaxel, Oxaliplatin and radiotherapy.
干预措施: oxaliplatin (Drug)
Chemoradiation Treated Patients
Patients receiving Docetaxel, Oxaliplatin and radiotherapy.
干预措施: radiation therapy (Procedure)
结局指标
主要结局
Maximum tolerated dose of oxaliplatin in combination with docetaxel and radiotherapy
时间窗: Within 90 days of radiotherapy
次要结局
- Dose-limiting toxicities(Within 90 days of radiotherapy)
- Objective tumor response(Every 3 months up to 24 months)