NCT00801385Unknown2 期
A Multicenter, Open-label, Phase II Study of Sorafenib in Combination With Erlotinib in Non-small Cell Lung Cancer (NSCLC) Refractory to One or Two Prior Chemotherapy Regimens
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Tumor response based on RECIST criteria
研究概览
简要总结
RATIONALE: Sorafenib and erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving sorafenib together with erlotinib may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving sorafenib together with erlotinib works in treating patients with stage IIIB or stage IV non-small cell lung cancer that has not responded to chemotherapy.
详细描述
OBJECTIVES:
Primary
- To assess the response rate of sorafenib tosylate in combination with erlotinib hydrochloride in patients with stage IIIB-IV non-small cell lung cancer refractory to 1 or 2 prior chemotherapy regimens.
Secondary
- To assess the response duration in patients treated with this regimen.
- To assess the disease control rate in patients treated with this regimen.
- To assess the progression-free survival of patients treated with this regimen.
- To assess the overall survival of patients treated with this regimen.
- To assess the safety and tolerability of this regimen in these patients.
- To analyze biomarkers, including evaluation of EGFR expression, mutational analysis of EGFR and K-ras, and immunohistochemical analysis of EGFR downstream pathway (phospho-EGFR, phospho-AKT, phospho-Erk, phospho-STAT3).
研究设计
- 研究类型
- Interventional
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed non-small cell lung cancer
- •Advanced (stage IIIB-IV) or recurrent disease
- •Must have failed 1 or 2 prior chemotherapy regimens, including platinum-containing regimen
- •At least 1 unidimensionally measurable lesion > 10 mm by spiral CT scan or > 20 mm by conventional CT scan
- •Previously irradiated lesions cannot be included as sites of measurable disease unless clear tumor progression has been documented in the lesions since the end of radiotherapy
- •No known or suspected brain metastases
- •Patients with clinical signs or symptoms that are suspicious of brain metastasis must have a pre-treatment CT scan or MRI of the brain
- •Patients with prior brain metastases are eligible provided they have completed their treatment for brain metastases, no longer require corticosteroids, and are asymptomatic
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •WBC 4,000-12,000/μL
- •Neutrophil ≥ 1,500/μL
- •Platelet count ≥ 100,000/μL
- •Hemoglobin ≥ 9.0 g/dL
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.0 times ULN
- •Alkaline phosphatase ≤ 2.0 times ULN
- •Serum creatinine ≤ 1.5 times ULN
- •Not pregnant or nursing
- •No active clinically serious infections
- •No prior or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1), or any cancer curatively treated > 5 years before study
- •Able to swallow oral medications
- •No substance abuse or medical, psychological, or social conditions that may interfere with participation in the study or evaluation of the study results
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Recovered from all prior therapy
- •No prior anti-EGFR targeted therapy
- •At least 4 weeks since prior surgery
- •At least 4 weeks since prior and no concurrent radiotherapy
- •No prior radiotherapy to the whole pelvis or chest or to ≥ 25% of the bone marrow
- •No other concurrent anticancer agents (e.g., chemotherapy or immunotherapy agents) which might affect evaluation of study treatment
排除标准
- 未提供
结局指标
主要结局
Tumor response based on RECIST criteria
次要结局
- Response duration in patients with confirmed objective response
- Disease control rate
- Overall survival
- Progression-free survival
- Biomarker analysis
研究者
研究点 (1)
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