Phase II Study of the Raf Kinase Inhibitor BAY43-9006 in Patients With Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Confirmed tumor response according to RECIST criteria
研究概览
简要总结
This phase II trial is studying how well sorafenib works in treating patients with stage IIIB or stage IV non-small cell lung cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor.
详细描述
PRIMARY OBJECTIVES:
I. Determine the response rate in patients with stage IIIB or IV non-small cell lung cancer treated with sorafenib.
II. Determine the clinical toxic effects of this drug in these patients.
SECONDARY OBJECTIVES:
I. Determine the 24-week progression-free survival rate in patients treated with 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
- •Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria:
- •Stage IIIB with pleural effusion
- •Measurable disease
- •At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan
- •The following are not considered measurable disease:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Inflammatory breast disease
- •Lymphangitis cutis/pulmonis
- •Abdominal masses not confirmed and followed by imaging techniques
- •Cystic lesions
- •No known brain metastases, even if treated and stable
- •Performance status - ECOG 0-2
- •At least 12 weeks
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 10 g/dL
- •No bleeding diathesis
- •Bilirubin ≤ 2 times upper limit of normal (ULN)
- •AST ≤ 3 times ULN (5 times ULN if hepatic metastasis present)
- •Creatinine ≤ 1.5 times ULN
- •No uncontrolled hypertension
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No known HIV positivity
- •HIV negative
- •Able to swallow tablets
- •No uncontrolled infection
- •No other severe underlying disease that would preclude study participation
- •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas
- •No prior immunotherapy, biologic therapy, or gene therapy
- •No concurrent prophylactic colony-stimulating factors
- •At least 4 weeks since prior low-dose weekly chemotherapy as a radiosensitizer
- •No other prior chemotherapy for NSCLC
- •No concurrent chemotherapy
- •See Chemotherapy
- •At least 4 weeks since prior radiotherapy
- •No prior radiotherapy to ≥ 30% of bone marrow
- •No concurrent radiotherapy
- •Concurrent palliative radiotherapy to nontarget lesions (e.g., painful pre-existing bony metastasis) allowed
- •Prior adjuvant therapy allowed provided recurrent disease occurred > 6 months after completion of adjuvant therapy
- •No prior systemic therapy for NSCLC, including all novel targeted agents (e.g., gefitinib or erlotinib)
- •No concurrent therapeutic anticoagulation
- •Prophylactic anticoagulation (e.g., low-dose warfarin) for venous and arterial devices allowed provided PT, INR, and PTT requirements are met
- •No other concurrent anticancer agents or therapies
- •No other concurrent investigational agents or therapies
排除标准
- 未提供
研究组 & 干预措施
Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: sorafenib tosylate (Drug)
Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days 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
Confirmed tumor response according to RECIST criteria
时间窗: Up to 5 years
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated using the Duffy-Santner approach.
次要结局
- Progression-free survival(At 24 weeks)
- Survival time(From registration to death due to any cause, assessed up to 5 years)
- Time-to-disease progression(From registration to documentation of disease progression, assessed up to 5 years)