Alternating Phase I/II Trials of Twice-Weekly Infusion Gemcitabine (2'2'-Difluoro-2'-Deoxycytidine) and Concurrent Thoracic Radiation Alone - Or Following 2 Cycles of Cisplatin/Gemcitabine Induction Chemotherapy for the Treatment of Stage IIIA/IIIB Non Small Cell Lung Cancer (NSCLC)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- •Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to compare the effectiveness of gemcitabine with radiation therapy alone or following two-drug combination chemotherapy in treating patients with stage III non-small cell lung cancer.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy alone or following 2 cycles of induction chemotherapy in patients with Stage IIIA or IIIB non-small cell lung cancer.
- Assess the toxicity of concurrent thoracic radiation and gemcitabine in these patients.
- Determine the effectiveness of concurrent radiation and gemcitabine by determining the complete response rate, partial response rate, time to recurrence, pattern of recurrence, and overall survival in a cohort of these patients.
OUTLINE: This is an alternating two arm, dose escalation, multicenter study.
Arm I: Patients receive twice-weekly gemcitabine as a 30 minute infusion. Concurrent radiation therapy is administered 5 days a week for 6 weeks.
Arm II: Patients receive 2 cycles of induction chemotherapy consisting of gemcitabine as a 30 minute infusion on day 1 and 8 and cisplatin IV over 1 hour on day 1. Each cycle is 21 days. Patients then receive gemcitabine and radiation therapy as in arm I.
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
- — 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed stage IIIA or IIIB non-small cell lung cancer that is unicentric and inoperable, including the following cellular types:
- •Squamous cell carcinoma
- •Adenocarcinoma
- •Bronchoalveolar carcinoma
- •Large cell anaplastic carcinoma
- •Non-small cell lung cancer not otherwise specified
- •Tumors may be multifocal if all of disease is believed to be result of direct spread
- •Disease must be fully accessible by radiotherapy ports for the entire prescribed dose
- •No supraclavicular nodes or diffuse pleural involvement
- •No contralateral hilar disease or an exudative, bloody, or cytologically malignant effusion
- •Measurable disease required for phase II of this study
- •PATIENT CHARACTERISTICS:
- •Performance status:
- •Life expectancy:
- •At least 1 year
- •Hematopoietic:
- •Granulocyte count at least 1,500/mm3
- •Platelet count at least 100,000/mm3
- •Hemoglobin greater than 10 g/dL
- •Bilirubin no greater than 2.0 mg/dL
- •BUN no greater than 1.5 times normal
- •Creatinine no greater than 1.5 times normal
- •FEV1 no greater than 1 liter except if tumor has negatively impacted
- •pulmonary function
- •No other serious medical or psychiatric illness
- •No prior lung cancer except if free of disease for more than 3 years
- •No other prior malignancy except nonmelanoma skin cancer or if free of
- •disease for more than 1 year
- •Not pregnant or nursing
- •Negative pregnancy test
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior thoracic radiotherapy
- •Concurrent radiotherapy to other anatomic sites allowed
- •Not specified
排除标准
- 未提供
结局指标
主要结局
•Determine the maximum tolerated dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy
时间窗: 6 weeks
次要结局
- assess the efficacy of dose of twice-weekly gemcitabine when delivered concurrently with thoracic radiotherapy(72 days)