NCT00619021终止1 期
A Phase I Study Evaluating Bronchial Artery Infusion (BAI) of Gemcitabine in Recurrent or Progressive Non-Small Cell Lung Cancer
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
- 4
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose and dose-limiting toxicity of gemcitabine hydrochloride when administered via bronchial artery infusion
研究概览
简要总结
RATIONALE: Bronchial artery infusion uses a catheter to deliver antitumor substances directly to the lungs. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving gemcitabine in different ways may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of gemcitabine given by bronchial artery infusion and to see how well it works in treating patients with recurrent or progressive non-small cell lung cancer.
详细描述
OBJECTIVES:
Primary
- To establish the maximum tolerated dose of gemcitabine hydrochloride delivered via bronchial artery infusion in patients with recurrent or progressive non-small cell lung cancer.
Secondary
- To evaluate local response in patients treated with this therapy.
- To characterize the pharmacokinetics of gemcitabine hydrochloride in patients treated with this 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
- •Cytologically or histologically confirmed non-small cell lung cancer meeting the following criteria:
- •No T2 lesions invading the visceral pleura, causing atelectasis, or proximal to an obstructing pneumonia
- •No T3 lesions invading the chest wall (including the parietal pleura, musculature, and/or rib), mediastinal pleura, diaphragm, or pericardium
- •No T4 lesions invading the heart, great vessels, carina, or esophagus
- •Must have disease that is incurable by standard treatment, defined as a minimum of first-line therapy with a platinum-containing regimen and second-line therapy with docetaxel, pemetrexed disodium, or erlotinib hydrochloride
- •Measurable or nonmeasurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •Life expectancy ≥ 12 weeks
- •Hemoglobin ≥ 9.0 g/dL
- •Absolute neutrophil count (ANC) ≥ 1,500/mm³
- •Platelet count ≥ 100,000/mm³
- •Serum creatinine ≤ 3.0 mg/dL
- •Total bilirubin < 1.5 times upper limit of normal
- •International normalized ratio (INR) ≤ 1.3
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective non-hormonal contraception
排除标准
- •Superior vena cava syndrome or superior sulcus tumors
- •Patients with airway obstructing lesions, or patients experiencing hemoptysis, dyspnea, chest pain, and/or copious sputum production may be eligible after careful consideration by the study physicians
- •Prior or concurrent malignancy except inactive nonmelanoma skin cancer, carcinoma in situ of the cervix, stage I carcinoma of the prostate with normal PSA, or other cancer from which the patient has been disease free for 3 years
- •Medical conditions that would make this protocol unreasonably hazardous, in the opinion of the treating physician, including any of the following:
- •Uncontrolled infection (including HIV)
- •Poorly controlled diabetes mellitus
- •Active cardiac disease (i.e., unstable angina, myocardial infarction within the past 6 months, or congestive heart failure)
- •Other serious medical illness that would limit survival to < 3 months, or psychiatric condition that would prevent informed consent, unless a legal guardian is available
- •Must consent to participate in the laboratory study, "Population Pharmacokinetics and Pharmacogenetics of Gemcitabine in Adult Patients with Solid Tumors" during course 1
- •More than 6 months since prior gemcitabine hydrochloride
- •More than 2 weeks since other prior chemotherapy
- •More than 4 weeks since prior radiotherapy
研究组 & 干预措施
Cohort 1
Experimental
Patient receives gemcitabine 600 mg/m^2.
干预措施: gemcitabine hydrochloride (Drug)
Cohort 2
Experimental
Patient receives gemcitabine 800 mg/m^2.
干预措施: gemcitabine hydrochloride (Drug)
Cohort 3
Experimental
Patient receives gemcitabine 1000 mg/m^2.
干预措施: gemcitabine hydrochloride (Drug)
Cohort 4
Experimental
Patient receives gemcitabine 1200 mg/m^2.
干预措施: gemcitabine hydrochloride (Drug)
结局指标
主要结局
Maximum tolerated dose and dose-limiting toxicity of gemcitabine hydrochloride when administered via bronchial artery infusion
时间窗: At time of dose-limiting toxicity
次要结局
- Local response as measured by RECIST(Week 8)
研究者
研究点 (1)
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