ACTRN12611001142921终止2 期
A randomised phase II study evaluating tumour response to Dual inhibition of EGFR signalling using CetUXimab and Erlotinib or dose escalated Cetuximab in patients with chemotherapy refractory KRAS wild-type metastatic colorectal cancer
Australasian Gastrointestinal Trials Group (AGITG)0 个研究点目标入组 180 人开始时间: 2011年11月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Males or females with histologically confirmed colorectal cancer.
- •2. Age greater than or equal to 18 yrs.
- •3. Metastatic disease not amendable to resection, as confirmed by the investigator.
- •4. Metastatic disease which is assessable by CT scan using RECIST v1.1 criteria.
- •5. KRAS wild type tumour status, confirmed by means of mutation analysis performed on representative samples of diagnostic tumour tissue.
- •6. Received and failed fluoropyrimidine therapy, where failure is defined as radiological progression after therapy for metastatic disease, prior adjuvant therapy, or toxicity limiting further therapy.
- •7. Received and failed oxaliplatin therapy, where failure is defined as radiological progression after therapy for metastatic disease, prior adjuvant therapy, or toxicity limiting further therapy.
- •8. Received and failed irinotecan therapy, where failure is defined as radiological progression after therapy for metastatic disease or toxicity limiting further therapy.
- •9. ECOG performance status of 0 or 1.
- •10. Adequate bone marrow function with platelets >100 X 10^9/l and ANC > 1.5 X 10^9/l.
- •11. Adequate renal function (creatinine clearance >40 ml/min using the Cockcroft Gault formula.
- •12. Adequate hepatic function (serum bilirubin < 1.25 X ULN, and either ALT or AST <2.5 X ULN (or <5 X ULN if liver metastases present).
- •13. Life expectancy of at least 12 weeks.
- •14. Study treatment both planned and able to start within 14 days of randomisation.
- •15. Willing and able to comply with all study requirements, including treatment (e.g. able to swallow tablets), timing and/or nature of required assessments.
- •16. Signed, written informed consent.
排除标准
- •1. Prior treatment with drugs targeting EGFR such as Cetuximab, Panitumumab or Erlotinib.
- •2. Participation in any investigational drug study within 4 weeks prior to planned study treatment start date.
- •3. Patients with uncontrolled clinically significant cardiac disease, arrhythmias or angina pectoris.
- •4. Untreated CNS metastases.
- •5. Other concurrent uncontrolled medical conditions.
- •6. Other malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other cancer treated with curative intent >2 years previously without evidence of relapse.
- •7. Patients with a tetracycline allergy will be excluded from the second randomisation only.
- •8. Pregnancy, lactation, or inadequate contraception. Women must be post menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to the first randomisation. Men must have been surgically sterilised or use a (double if required) barrier method of contraception.
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