Randomized Phase II Study of Cetuximab in Combination With Gemcitabine or Gemcitabine Followed by Cetuximab in Advanced Non Small-cell Lung Cancer Patients Who Are Not Candidates for Platinum Based Therapy.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 25
- 主要终点
- one year survival rate
研究概览
简要总结
The purpose of this study is to select the more promising method of combining cetuximab with gemcitabine for treating patients with advanced non small-cell lung cancer, who are not candidates for platinum based therapy.
详细描述
The standard treatment for advanced non small cell lung cancer (NSCLC) is combination chemotherapy with cisplatin or carboplatin. Due to its toxicity, this therapy may not be suited for certain patients including the elderly, those whose general condition is poor. Combining chemotherapy with a biologic agent ("targeted therapy") is a new strategy being evaluated for the treatment of NSCLC, and cetuximab is one of the drugs that has shown promise for its activity and tolerability. This study aims to determine the more promising of 2 methods of combining gemcitabine with cetuximab (in combination vs. sequential administration), in two groups of patients who are not candidates for combination platinum based chemotherapy: patients under age 70 with performance status 2 (expected enrollment 42) , and patients over age 70 (expected enrollment 58).
Patients will be randomly assigned to one of two treatment arms:
-
Arm A: Cetuximab + Gemcitabine:
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Cetuximab given intravenously weekly AND
-
Gemcitabine given intravenously for a maximum of 6 cycles (on days 1 and 8 of each 3 week cycle)
-
Arm B: Gemcitabine followed by Cetuximab:
-
Gemcitabine given intravenously for a maximum of 6 cycles (on days 1 and 8 of each 3 week cycle) THEN
-
Cetuximab given intravenously weekly
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent
- •Age > 18
- •Histological diagnosis of non small-cell lung cancer (NSCLC)
- •Stage III B or Stage IV disease
- •Contraindications to platinum based therapy (age > 70 or age < 70 with ECOG performance status 2)
- •At least one site of metastasis (target or non-target)
- •Life expectancy of at least 3 months
- •Neutrophils > 1500/mm3, platelets > 100,000/mm3, hemoglobin > 9g/dl
- •Bilirubin < 1.5 x the upper normal limit
- •SGOT and SGPT < 2.5 x the upper normal limits (< 5 x the upper normal limit in the presence of hepatic metastasis)
- •Creatinine < 1.5 x the upper normal limit
- •Adequate method of contraception (male and female), when there is risk of conception.
排除标准
- •Symptomatic cerebral metastasis
- •Previous chemotherapy for advanced disease
- •Adjuvant chemotherapy within the previous 6 months
- •Radiation therapy within previous 4 weeks
- •Any experimental drug therapy within the previous 4 weeks
- •Previous exposure to monoclonal antibodies, signal transduction inhibitors or EGFR targeting therapy
- •Clinically relevant cardiopathy or myocardial infarct within the last 12 months
- •Acute or subacute intestinal occlusion or history of inflammatory bowel disease
- •Known allergy to one or more of the experimental treatments
- •Known alcohol or substance abuse
- •Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or give informed consent
- •Pregnant or breastfeeding females
- •History of malignant neoplasm within the previous 5 years (not including non-melanoma skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
研究组 & 干预措施
A
cetuximab and gemcitabine combination
干预措施: cetuximab (Drug)
A
cetuximab and gemcitabine combination
干预措施: gemcitabine (Drug)
B
gemcitabine followed by cetuximab (sequential)
干预措施: gemcitabine (Drug)
B
gemcitabine followed by cetuximab (sequential)
干预措施: cetuximab (Drug)
结局指标
主要结局
one year survival rate
时间窗: one year
次要结局
- toxicity(weekly)
- overall survival(18 months)
- overall response rate(one year)
- prognostic role of cetuximab associated skin toxicities(one year)