A Phase II Study of Dasatinib (NSC #732517) in Patients With Chemo-Sensitive Relapsed Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- 6 Week Progression Free Survival
研究概览
简要总结
This phase II trial is studying how well dasatinib works in treating patients with relapse small cell lung cancer. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
详细描述
PRIMARY OBJECTIVE I. Determine the efficacy of dasatinib in patients with relapsed small cell lung cancer.
SECONDARY OBJECTIVE II. Determine the objective response rate (complete and partial response) in patients treated with this drug.
III. Determine the overall survival of patients treated with this drug. IV. Determine the toxicity of this drug in these patients.
OUTLINE:
Patients receive oral dasatinib twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
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
- •Histologically or cytologically confirmed small cell lung cancer (SCLC) (limited or extensive stage disease)
- •Progressive or recurrent disease after an initial response to first-line treatment with a platinum-based chemotherapy with or without concurrent definitive radiotherapy to the chest (chemotherapy must have been completed at least 90 days prior to documentation of relapse)
- •Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- •Lesions that are not considered measurable include the following:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural or pericardial effusion
- •Abdominal masses that are not confirmed and followed by imaging techniques
- •Cystic lesions
- •Tumor lesions situated in a previously irradiated area, unless progression after radiotherapy is documented in these lesions
- •No known brain metastases (previously treated brain metastases allowed provided they are neurologically stable for >= 4 weeks)
- •ECOG performance status 0-1
- •Platelet count >= 100,000/mm^3
- •Bilirubin =< 1.5 times upper limit of normal (ULN)
- •Creatinine =< 1.5 times ULN OR creatinine clearance >= 60 mL/min
- •AST =< 2.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •No significant cardiac disease, including any of the following:
- •New York Heart Association class III-IV heart disease
- •Myocardial infarction or ventricular tachyarrhythmia within the past 6 months
- •Prolonged QTc > 480 msec (Fridericia correction)
- •Major conduction abnormality (unless a cardiac pacemaker is present)
- •No more than 1 prior chemotherapy regimen
- •No prior dasatinib or compounds of similar chemical composition or similar biologic therapeutic activity including, but not limited to, any inhibitors of SRC, BCR-ABL, c-KIT, EPHA2, or PDGFRB kinases
- •At least 2 weeks since prior definitive or palliative radiotherapy (prior radiotherapy allowed in the context of combined modality treatment with curative intent for limited stage disease; prophylactic cranial radiotherapy; or palliative radiotherapy initially or at relapse)
- •At least 2 weeks since prior surgery and recovered
- •At least 1 week since prior and no concurrent agents with proarrhythmic potential
- •At least 1 week since prior and no concurrent CYP3A4 inhibitors or inducers
- •At least 1 week since prior and no concurrent grapefruit concentrate
- •No concurrent palliative radiotherapy
- •No concurrent hormones or other chemotherapeutic agents, except steroids for adrenal failure, hormones for noncancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No other concurrent chemotherapeutic or investigational agents
- •Fertile patients must use effective contraception during and for >= 6 weeks after completion of study therapy
排除标准
- 未提供
研究组 & 干预措施
Treatment (dasatinib)
Patients receive 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
6 Week Progression Free Survival
时间窗: 6 weeks
Percentage of patients who were alive and progression free at 6-weeks. The 6-week progression free survival was estimated using the Kaplan Meier method. Progressive Disease was defined by the Response Evaluation Criteria In Solid Tumors (RECIST) criteria as 20% increase in sum of longest diameter of target lesions.
次要结局
- Progression Free Survival (PFS)(Time from registration to progression (up to 3 years))
- Response to Therapy(Assessed every 2 cycles (up to 3 years))
- Overall Survival(Time from registration to death (up to 3 years))
- Number of Participants With Grade 3 or Higher Adverse Events(Assessed during treatment)