NCT00254137已完成2 期
A Randomized Phase II-study to Evaluate the Safety and Efficacy of Capecitabine Plus Irinotecan Plus Cetuximab Compared to Capecitabine Plus Oxaliplatin Plus Cetuximab in First-line Treatment of Patients With Metastatic Colorectal Cancer.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 92
- 主要终点
- Objective response rate (CR+PR)
研究概览
简要总结
A randomized phase II-study to evaluate the safety and efficacy of capecitabine plus irinotecan plus cetuximab compared to capecitabine plus oxaliplatin plus cetuximab in first-line treatment of patients with metastatic colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic colorectal cancer.
- •EGF-receptor testing.
- •No prior chemotherapy for colorectal cancer (except adjuvant chemotherapy with an interval ³ 6 months).
- •No prior therapy with topoisomerase-1 inhibitors, no prior therapy directed against the EGF-pathway.
- •No prior surgery (except diagnostic biopsy) or radiation therapy 4 weeks before start of study treatment.
- •Measurable disease (diameter ³ 20mm, diameter ³ 10mm with spiral-CT).
- •Male and female patients ³ 18 years, £ 75 years. Karnofsky PS ³ 70%. Life expectancy ³ 3 months. Effective contraception if risk of conception exists.
- •Adequate bone marrow, liver and renal function (leucocytes ³3.000/µl, neutrophils ³1.500/µl, platelets ³100.000/µl, hemoglobin ³9g/dl, bilirubin £1,5x ULN, ASAT and ALAT £3x ULN (£5x ULN with liver metastasis), serum creatinine £1,5x ULN).
- •Written informed consent.
排除标准
- •Concurrent treatment of colorectal cancer (except study medication).
- •EGF-receptor testing not possible.
- •Known DPD-deficiency (no particular screening necessary). Known Gilbert-Meulengracht-Syndrome (no particular screening necessary).
- •Known or expected contraindication against study medication.
- •Participation in other studies during 30 days before study entry.
- •Prior myocardial infarction, severe renal insufficiency (creatinine clearance £30ml/min).
- •Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment and no sign of disease during 5 years).
- •Known or suspected cerebral metastasis.
- •History of inflammatory bowel disease. Symptomatic peritoneal carcinomatosis.
- •Drug or alcohol abuse. Lack of adequate legal capacity.
- •Breast-feeding or pregnant women.
- •Concurrent medication with Sorivudine and analoga, anticoagulation with Cumarine or derivatives.
结局指标
主要结局
Objective response rate (CR+PR)
次要结局
- Time to progression.
- Disease control rate (CR+PR+SD).
- Safety profile.
- Grade 3/4- toxicities.
研究者
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