Phase II Trial of STI571 in Patients With Relapsed Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- The proportion of patients progression-free
研究概览
简要总结
Phase II trial to study the effectiveness of imatinib mesylate in treating patients who have recurrent small cell lung cancer. Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.
详细描述
PRIMARY OBJECTIVES:
I. Determine the response rate, time to progression, and overall survival of patients with recurrent small cell lung cancer treated with imatinib mesylate.
II. Correlate the presence of c-Kit mutations in tumor tissue with treatment response in patients treated with this drug.
III. Correlate individual patient variation in clinical (toxicity and/or activity), pharmacologic (pharmacokinetic/pharmacodynamic parameters), and/or biologic (correlative laboratory study results) responses to this drug with genetic differences in proteins involved in drug response (transport, metabolism, and/or mechanism of action).
OUTLINE: This is a multicenter study. Patients are stratified according to length of prior therapy (less than 3 months vs at least 3 months).
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)
- •No mixed histology
- •Must have received only 1 prior treatment regimen (e.g., cyclophosphamide, doxorubicin, and vincristine alternating with etoposide and cisplatin allowed)
- •c-Kit positive by immunohistochemistry (at least 1+)
- •At least 1 unidimensionally measurable lesion
- •Longest diameter at least 20 mm
- •No uncontrolled CNS metastasis
- •Treated CNS metastasis allowed
- •Performance status - ECOG 0-2
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9 g/dL
- •Total bilirubin no greater than 1.5 times upper limit of normal (ULN)
- •Direct bilirubin no greater than ULN
- •Creatinine no greater than 1.5 times ULN
- •No unstable angina pectoris
- •No uncontrolled congestive heart failure within the past 3 months unless ejection fraction is greater than 40%
- •No myocardial infarction within the past 3 months
- •No uncontrolled infection
- •No other malignancy within the past 3 years except skin cancer or localized prostate cancer
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for at least 3 months after study participation
- •See Disease Characteristics
- •More than 3 weeks since prior chemotherapy
- •More than 2 weeks since prior radiotherapy
- •No concurrent radiotherapy(including palliative therapy for bone pain)
- •Concurrent whole-brain radiotherapy for CNS progression allowed
- •More than 3 weeks since prior major surgery
- •No prior imatinib mesylate
排除标准
- 未提供
研究组 & 干预措施
Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate twice daily for 28 days. Courses continue in the absence of disease progression or unacceptable toxicity.
干预措施: imatinib mesylate (Drug)
Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate twice daily for 28 days. Courses continue in the absence of disease progression or unacceptable toxicity.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
The proportion of patients progression-free
时间窗: 16 weeks
Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner.
次要结局
- Survival time(From registration to death due to any cause, assessed up to 3 years)
- Time to disease progression(From randomization to documentation of disease progression, assessed up to 3 years)
- Duration of response (complete response [CR] or partial response [PR])(The date from which the patient's objective status if first noted to be either a CR or PR to the date progression is documented, assessed up to 3 years)
- Time to treatment failure(From the date of registration to the date at which the patient is removed from treatment due to progression, toxicity, refusal, or death, assessed up to 3 years)
- Toxicity defined as adverse events that are classified as either possibly, probably, or definitely related to study treatment, per the National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 2.0(Up to 3 years)