A Phase II Study of OSI 774 (IND Number 63383) in Combination With Celecoxib (Celebrex, Pharmacia) as Second-Line Therapy in Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST)
研究概览
简要总结
This phase II trial is studying how well giving erlotinib together with celecoxib works in treating patients with recurrent stage IIIB or stage IV non-small cell lung cancer. Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of a tumor by stopping blood flow to the tumor. Combining erlotinib with celecoxib may kill more tumor cells.
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详细描述
PRIMARY OBJECTIVES:
I. Determine the response rate of patients with stage IIIB or IV recurrent non-small cell lung cancer treated with erlotinib and celecoxib as second-line therapy.
SECONDARY OBJECTIVES:
I. Determine the time to progression in patients treated with this regimen. II. Determine the survival duration of patients treated with this regimen. III. Determine the toxicity of this regimen in these patients. IV. Correlate the expression of epidermal growth factor receptor and cyclooxygenase-2 in tumor specimens with response, time to progression, and survival in patients treated with this regimen.
OUTLINE: Patients are assigned to 1 of 2 treatment groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Stage IIIB (malignant pleural effusion only) or IV
- •Recurrent disease that has progressed after 1 or 2 prior chemotherapy regimens (platinum- or nonplatinum-based)
- •At least 1 unidimensionally measurable lesion*
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •Must have tissue specimen available for assays
- •No brain metastases
- •Performance status - ECOG 0-2
- •Performance status - Karnofsky 60-100%
- •More than 3 months
- •WBC at least 3,000/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Bilirubin normal
- •AST/ALT no greater than 2.5 times upper normal limit (ULN)
- •Creatinine normal
- •Creatinine clearance at least 60 mL/min
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •No prior abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome)
- •No congenital abnormality (e.g., Fuch's dystrophy)
- •No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose)
- •No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test)
- •Able to ingest oral medication
- •No requirement for IV alimentation
- •No history of peptic ulcer disease
- •No active gastrointestinal ulcers
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other concurrent uncontrolled illness
- •No ongoing or active infection
- •No significant traumatic injury within the past 21 days
- •No psychiatric illness or social situation that would preclude study compliance
- •No prior allergic reactions to sulfonamides, aspirin, and other nonsteroidal anti-inflammatory drugs
- •No prior monoclonal antibodies to epidermal growth factor receptor (EGFR)
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
- •No concurrent chemotherapy
- •No concurrent glucocorticoids
- •More than 4 weeks since prior radiotherapy and recovered
- •More than 21 days since prior major surgery
- •No prior surgery affecting absorption
- •No prior EGFR-specific tyrosine kinases
- •No concurrent anticonvulsants
- •No other concurrent investigational agents
- •No concurrent antiretroviral therapy for HIV-positive patients
- •No concurrent antacids
- •No concurrent administration of any of the following drugs:
- •Amiodarone
- 另有 23 项未显示
排除标准
- 未提供
研究组 & 干预措施
Group I (erlotinib hydrochloride, celecoxib)
Patients receive oral erlotinib once daily and oral celecoxib twice daily.
干预措施: erlotinib hydrochloride (Drug)
Group I (erlotinib hydrochloride, celecoxib)
Patients receive oral erlotinib once daily and oral celecoxib twice daily.
干预措施: celecoxib (Drug)
Group I (erlotinib hydrochloride, celecoxib)
Patients receive oral erlotinib once daily and oral celecoxib twice daily.
干预措施: laboratory biomarker analysis (Other)
Group II (erlotinib hydrochloride)
Patients receive erlotinib as in group 1.
干预措施: erlotinib hydrochloride (Drug)
Group II (erlotinib hydrochloride)
Patients receive erlotinib as in group 1.
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST)
时间窗: From the start of treatment until disease progression/recurrence, assessed up to 5 years
次要结局
- Overall survival(Up to 5 years)
- Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0(Up to 5 years)
- Time to progression(Interval between start of treatment with erlotinib hydrochloride and celecoxib and the date on which progressive disease, assessed up to 5 years)
- Relationship between measures of treatment efficacy and EGFR and COX-2 levels(Up to 5 years)