NCT00079066已完成3 期
A Phase III Randomized Study of Cetuximab (Erbitux™, C225) and Best Supportive Care Versus Best Supportive Care in Patients With Pretreated Metastatic Epidermal Growth Factor Receptor (EGFR)-Positive Colorectal Carcinoma
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 572
- 试验地点
- 33
- 主要终点
- Overall survival
研究概览
简要总结
RATIONALE: Monoclonal antibodies, such as cetuximab, can target tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Best supportive care is the use of drugs and other treatments to improve the quality of life of patients. Combining cetuximab with best supportive care may slow the growth of the tumor and help patients live longer and more comfortably. It is not yet known whether cetuximab combined with best supportive care is more effective than best supportive care alone in treating metastatic epidermal growth factor receptor-positive colorectal cancer.
PURPOSE: This randomized phase III trial is studying cetuximab and best supportive care to see how well they work compared to best supportive care alone in treating patients with metastatic epidermal growth factor receptor-positive colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Compare survival of patients with metastatic epidermal growth factor receptor-positive colorectal cancer treated with cetuximab and best supportive care vs best supportive care alone.
Secondary
- Compare the time to disease progression in patients treated with these regimens.
- Compare the objective response rate in patients treated with these regimens.
- Compare the quality of life of patients treated with these regimens.
- Compare the health utilities of patients treated with these regimens.
- Conduct a comparative economic evaluation in patients treated with these regimens.
- Determine the safety profile of cetuximab in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 120 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed colorectal cancer
- •Metastatic disease
- •Epidermal growth factor receptor (EGFR)-positive by immunochemistry
- •Measurable or evaluable disease
- •Not amenable to standard curative therapy
- •Best supportive care is the only available option
- •Must have received a prior thymidylate synthase inhibitor (e.g., fluorouracil, capecitabine, raltitrexed, or fluorouracil-uracil) in the adjuvant or metastatic setting
- •Combination therapy with oxaliplatin or irinotecan allowed
- •Must have failed* a prior regimen containing irinotecan and a prior regimen containing oxaliplatin for metastatic disease OR relapsed within 6 months after an adjuvant regimen containing irinotecan or oxaliplatin OR have documented unsuitability for such regimens
- •No symptomatic CNS metastases NOTE: *Failure is defined as either disease progression (clinical or radiological) or intolerance to the regimen
- •PATIENT CHARACTERISTICS:
- •16 and over
- •Performance status
- •Life expectancy
- •Not specified
- •Hematopoietic
- •See Disease Characteristics
- •Absolute granulocyte count ≥ 1,500/mm^3
- •Platelet count ≥ 75,000/mm^3
- •Hemoglobin ≥ 8.0 g/dL
- •AST and ALT ≤ 5 times upper limit of normal (ULN)
- •Bilirubin ≤ 2.5 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Cardiovascular
- •No uncontrolled angina
- •No arrhythmias
- •No cardiomyopathy
- •No congestive heart failure
- •No myocardial infarction* within the past 6 months NOTE: *Pre-treatment ECG as only evidence of infarction is allowed
- •No severe restrictive lung disease
- •No interstitial lung disease by chest x-ray
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception for 4 weeks before, during, and for 4 weeks after study treatment
- •No active pathological condition that would preclude study participation
- •No psychological or geographical condition that would preclude study compliance
- •No other malignancy within the past 5 years except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •No prior cetuximab
- •No prior murine monoclonal antibody therapy (e.g., edrecolomab)
- •Chemotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior chemotherapy and recovered
- •No concurrent chemotherapy
- •Radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy and recovered
- •Concurrent palliative radiotherapy allowed except to index lesions
- 另有 7 项未显示
排除标准
- 未提供
结局指标
主要结局
Overall survival
次要结局
- Economic evaluation
- Quality of life by European Organization for Research of the Treatment of Cancer Quality of Life Questionnaire -C30 (EORTC QLQ-C30)
- Objective response rate
- Time to progression
- Health utilities by Health Utilities Index 13 (HU 13)
- Safety profile
研究者
研究点 (33)
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