A Phase I/II Clinical Trial Of Pulsed Paclitaxel And Daily Thoracic Radiotherapy For Inoperable (Stage I/II) Or Unresectable (Stage III) Lung Cancers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule.
研究概览
简要总结
A treatment study is being conducted by the University of Rochester Cancer Center (URCC) in which patients with non-small cell lung cancer will be treated with radiation therapy and a drug called paclitaxel. Paclitaxel is a natural product with anticancer properties. The first purpose of this study is to determine the dose of paclitaxel which, when given in combination with radiation therapy, will provide the greatest effect have the least side effects. To determine this, patients will be put on the study in groups of 3. The dose for each additional group will be higher than the previous dose until the maximum tolerated dose is reached. The second purpose is to determine if radiation therapy with paclitaxel is more effective in treating lung cancer than radiation therapy alone.
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
- •Histologically confirmed lung cancer, excluding small cell carcinoma
- •Inoperable stage I (T1-2N0) and II (T1-2N1, T3N0) disease, or stage IIIA (T3N1 andT1-3N2M0) and IIIB (TxN3M0, T4NxM0) diseases according to the American Joint Committee of Cancer criteria 1998
- •The primary tumor must be radiographically measurable.
- •Karnofsky performance status >
- •FEV1 sufficient for patients to tolerate radiation therapy which is at the discretion of the radiation oncologist, usually > 800 ml
- •Labs: WBC > 3000; platelet count > 100,000; serum creatinine < 1.5 mg/dl or creatinine clearance >60 ml/min.
- •Laboratory values must be obtained < 3 weeks prior to registration.
- •A signed informed consent.
- •Patients who failed prior chemotherapy are eligible. Patients with prior radiotherapy to the chest region are eligible as long as the normal tissue tolerance is not violated by repeat radiotherapy.
排除标准
- •Patients with medical contraindication to chemotherapy or radiotherapy.
- •Patients with myocardial infarction within the preceding six months or symptomatic heart disease, including uncontrolled or unstable angina, uncontrolled congestive heart failure, and uncontrolled arrhythmia.
- •Women who are pregnant.
- •Patients with small cell carcinoma or mesothelioma
研究组 & 干预措施
1st dose cohort 15mg/m2 taxol plus RT
15 mg/m2 Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
干预措施: Paclitaxel (Drug)
1st dose cohort 15mg/m2 taxol plus RT
15 mg/m2 Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.
On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible
干预措施: Radiation Therapy (Procedure)
2nd dose cohort20 mg/m2 taxol plus daily RT
干预措施: Paclitaxel (Drug)
2nd dose cohort20 mg/m2 taxol plus daily RT
干预措施: Radiation Therapy (Procedure)
3rd Dose Cohort --25mg/m2 taxol plus RT
干预措施: Paclitaxel (Drug)
3rd Dose Cohort --25mg/m2 taxol plus RT
干预措施: Radiation Therapy (Procedure)
Phase II Arm --20mg/m2 taxol plus RT
干预措施: Paclitaxel (Drug)
Phase II Arm --20mg/m2 taxol plus RT
干预措施: Radiation Therapy (Procedure)
结局指标
主要结局
Define the Maximum Tolerated Dose (MTD) Using This Dose Schedule.
时间窗: 5 years
次要结局
- Median Survival(86 months)
研究者
Yuhchyau Chen
Principal Investigator
University of Rochester