EUCTR2009-009992-36-BE进行中（未招募）1 期
A two arm phase II study of FOLFIRI in combination with standard or escalating dose of cetuximab as first line treatment of K-Ras wild type metastatic colorectal cancer: Everest 2 - Everest 2
niversity Hospital Leuven0 个研究点目标入组 375 人开始时间: 2010年9月10日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 375
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent (+ optional for PK and TR) must be given according to ICH/GCP and national/local regulations.
- •2. Patient is at least 18 years of age.
- •3. Patient’s body weight is = 120 kg.
- •4. Histologically proven and measurable (RECIST criteria v.1.1) metastatic adenocarcinoma of the colon or rectum, not in a previously irradiated area.
- •5. K-Ras wild type tumour eligible for treatment with cetuximab.
- •6. Unresectable metastatic disease.
- •7. Life expectancy of at least 12 weeks.
- •8. WHO ECOG performance status: 0 or 1.
- •9. Effective contraception for both male and female patients if the risk of conception exists.
- •10. Adequate organ function.
- •11. Adequate bone marrow, hepatic and renal function (assessed within 14 days prior to study entry):
- •- Hemoglobin >10.0 g/dL, absolute neutrophil count > 1.5 x 109/L, platelet count > 100 x 109/L
- •- ALAT, ASAT < 2.5 x ULN, up to < 5 x ULN in case of liver metastases
- •- Alkaline phosphatase < 2.5 x ULN
- •- Total bilirubin < 1.5 x ULN
- •- Creatinine clearance > 50 mL/min (calculated according to Cockroft and Gault)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Prior treatment for metastatic disease (adjuvant therapy with fluoropyrimidines +/-oxaliplatin based regimens allowed if stopped 6 months prior to registration on study).
- •2. Prior treatment with EGFR inhibitor or chemotherapy with irinotecan in adjuvant settings.
- •3. Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to study entry.
- •4. Administration of any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment.
- •5. Concurrent chronic systemic immune therapy, chemotherapy, radiation therapy or hormone therapy not indicated in the study protocol.
- •6. Any active dermatological condition > grade 1.
- •7. Brain metastasis (known or suspected).
- •8. Significant impairment of intestinal absorption (e.g. chronic diarrhea, inflammatory bowel disease).
- •9. Other uncontrolled concomitant illness, including serious uncontrolled intercurrent infection.
- •10. Uncontrolled coronary artery disease and/or unstable angina, a history of a myocardial infarction within the last 12 months or heart failure NYHA class III or IV. High risk of uncontrolled arrhythmia.
- •11. Known allergy or any other adverse reaction to any of the drugs or to any related compound.
- •12. Known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •13. Gilbert disease.
- •14. Previous (within 5 years) or concurrent malignancies at other sites with the exception of surgically cured or adequately treated carcinoma in-situ of the cervix and basal cell carcinoma of the skin.
- •15. Organ allografts requiring immunosuppressive therapy.
- •16. Pregnancy (absence confirmed by serum/urine beta human choriongonadotrophin in pre-menopausal women) or breast-feeding.
- •17. Medical, social or psychological condition which, in the opinion of the investigator, would not permit the patient to complete the study or sign meaningful informed consent.
研究者
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