NCT00378404终止1 期
A Phase I Trial of Docetaxel and Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To assess the MTD of low-dose fractionated radiation in combination with Docetaxel in recurrent or metastatic non-small cell lung cancer in the second-line setting.
研究概览
简要总结
The purpose of this study is to assess the maximum tolerated dose of low-dose radiation in combination with Docetaxel in recurrent or metastatic non-small cell lung cancer for second-line therapy.
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
- •Patients must be 18 years of age or greater.
- •Histologically or cytologically proven non-small cell lung cancer that is either metastatic or recurrent and failed at least one prior platinum-based chemotherapeutic regimen.
- •Patients who have recurred after previous surgery and/or radiation may participate in this trial.
- •Patients may have had prior neoadjuvant or adjuvant therapy.
- •Patients with known brain metastases are eligible for this clinical trial if their disease has been treated and they are clinically stable and documented by a stable or improved pretreatment CT or MRI scan of the brain to evaluate for CNS disease within 28 days prior to registration.
- •Measurable OR non-measurable disease documented by CT, MRI, X-ray or nuclear exam (FDG-PET). Measurable or non-measurable disease must be present outside the area of surgical resection. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease.
- •Progression after at least one prior platinum-based chemotherapy.
- •Greater than 3 weeks since surgery and must have recovered from all associated toxicities at time of registration.
- •ANC ≥ 1,500/µl and platelet count ≥ 100,000/µl obtained within 28 days prior to registration.
- •Adequate hepatic function documented by a serum bilirubin ≤ 1.5 times institutional upper limit of normal and liver enzymes (SGOT or SGPT) ≤ 2.5 x the institutional upper limit of normal obtained within 28 days prior to registration.
- •Patients requiring lung radiation must have an FEV1 of > 1000 liters obtained within 28 days prior to registration and must have pulmonary function tests with DLCO.
- •Zubrod Performance Status of 0,1 or 2.
排除标准
- •No prior single-agent, weekly Docetaxel chemotherapy.
- •Peripheral neuropathy ≥ Grade
- •Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 5 years.
- •Pregnant or nursing women.
研究组 & 干预措施
1
Experimental
干预措施: Docetaxel (Drug)
1
Experimental
干预措施: Radiation (Radiation)
结局指标
主要结局
To assess the MTD of low-dose fractionated radiation in combination with Docetaxel in recurrent or metastatic non-small cell lung cancer in the second-line setting.
时间窗: continuously through treatment
次要结局
- Toxicity(continuously throughout treatment)
- To investigate in an exploratory manner, the association of p53, p21^waf1/cip1, bcl-xL, bcl-2 and bax markers in pre- and post-treatment biopsies with patient response and toxicity.(week 1)
研究者
Susanne Arnold
Principal Investigator
University of Kentucky
研究点 (1)
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