Phase II Study of Dasatinib in Non Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with stage IIIB, stage IV, or recurrent non-small cell lung cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine the progression-free survival at 12 weeks in patients with stage IIIB or IV or recurrent non-small cell lung cancer treated with dasatinib.
SECONDARY OBJECTIVES:
I. Determine the rate of response in patients treated with this drug. II. Examine the relationship between clinical response to this drug and epidermal growth factor receptor (EGFR) mutational status, EGFR copy number, and (phosphorylated Src) pSrc expression levels in pre-treatment tumor biopsies.
III. Determine the toxicity of this drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Platelet count >= 100,000/mm^3
- •Histologically or cytologically confirmed non-small cell lung cancer meeting 1 of the following criteria:
- •Stage IV disease
- •Stage IIIB disease with pleural effusion
- •Recurrent disease after surgery or radiotherapy
- •Measurable disease, defined as >= 1 lesion that can be accurately measured in at least 1 dimension (longest diameter to be recorded) >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- •Previously treated brain metastasis allowed, provided there is no bleeding, no midline shift, no need for steroids or anti-convulsants, and no symptoms
- •Must agree to obtain residual tumor tissue available from the existing diagnostic biopsy tumor tissue
- •Eastern cooperative oncology group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 60-100%
- •Life expectancy > 12 weeks
- •White blood cell (WBC) >= 3,000/mm^3
- •Absolute neutrophil count >= 1,500/mm^3
- •Bilirubin =< 1.5 times upper limit of normal (ULN)
- •Aspartate aminotransferase (AST) and ALT =< 2.5 times ULN
- •Creatinine =< 3 times ULN OR Creatinine clearance >= 60 mL/min
- •No uncontrolled congestive heart failure or potentially life-threatening arrhythmia
- •No angina at rest
- •No neuropathy >= grade 2
- •No chronic diarrhea or history of inflammatory bowel disease
- •No history of pulmonary fibrosis (other than in an irradiated field)
- •No other concurrent serious medical illness
- •O2 saturation > 92% on room air
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No history of allergic reactions to compounds of similar chemical or biological composition to dasatinib
- •No heart rate-corrected QT interval (QTc) prolongation (i.e., QTC >= 480 msec) or other significant ECG abnormalities that could lead to adverse effects if the QTc interval were prolonged
- •No medical condition that impairs the ability to swallow, retain, or absorb dasatinib including, but not limited to, any of the following:
- •Gastrointestinal tract disease resulting in an inability to take oral medication, requirement for IV alimentation, prior surgical procedures affecting absorption, active peptic ulcer disease
- •No myocardial infarction or ventricular tachyarrhythmia within the past 6 months
- •left ventricular ejection fraction (LVEF) normal
- •No major conduction abnormality (unless cardiac pacemaker is present)
- •No ongoing or active infection
- •No history of significant bleeding disorder (congenital [von Willebrand's disease] or acquired [antifactor VIII antibodies])
- •No psychiatric illness or social situation that would preclude study compliance
- •No prior chemotherapy or biologic therapy for recurrent or metastatic non-small cell lung cancer
- •Adjuvant cytotoxic chemotherapy after surgical resection or chemotherapy with radiation for locally advanced disease (curative intent) allowed provided disease recurrence >= 3 months after completion of last chemotherapy dose
- •Measurable disease must be outside the radiotherapy port OR clearly growing inside the port
- •No prior radiotherapy to >= 25% of the marrow-containing skeleton
- •At least 7 days since prior and no concurrent medications that are inhibitors or inducers of CYP3A4
- •At least 7 days since prior and no concurrent agents with proarrhythmic potential
- •No other concurrent investigational agents
- •No other concurrent anticancer agents or therapies
- •No concurrent antiretroviral therapy for HIV-positive patients
- •No concurrent systemic antacids (H2 receptor antagonists and proton pump inhibitors)
- •Locally acting antacids allowed except for 2 hours before and after dasatinib administration
排除标准
- 未提供
研究组 & 干预措施
Arm I
Patients received oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
干预措施: dasatinib (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: Time from start of treatment to time of progression or death, assessed at 2 months
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death.
Number of Participants With Objective Response (Complete Response (CR) or Partial Response (PR))
时间窗: 12 weeks
Objective response defined as participants with Complete Response (CR) or Partial Response (PR) evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. RECIST definitions are Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least a 30% decrease in sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. Response measured by tumor size on computed tomography scans and by metabolic activity on positron emission tomography scans.
次要结局
未报告次要终点