EUCTR2012-003638-18-IT进行中（未招募）1 期
Randomised Phase II study of cetuximab alone or in combination with irinotecan in patients with metastatic colorectal cancer (CRC) with either KRAS WT or G13D mutation - ICE CREAM
AGITG (Australasian Gastro - Intestinal Trial Group)0 个研究点目标入组 100 人开始时间: 2013年7月29日最近更新:
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
- 100
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.Histologic or cytologic diagnosis of adenocarcinoma of the gallbladder or intra/extrahepatic bile ducts with locally advanced or metastatic disease (at study entry) that is not amenable to curative surgical resection or with recurrent disease after prior surgical resection or radiotherapy;
- •2.K-RAS wild-type oncogene;
- •3.Uni-dimensional measurable disease as assessed by CT scan (RECIST v1.1 criteria).
- •4.Patients must have received no prior chemotherapy or biological therapy for advanced disease;
- •5.Prior radiotherapy must be completed at least 4 weeks before study enrolment. Patients must have recovered from the acute toxic effects of the treatment prior to study enrolment;
- •6.WHO performance status 0, 1 or 2;
- •7.Estimated life expectancy of at least 12 weeks;
- •8.Patient compliance and geographic proximity that allows adequate follow-up;
- •9.Adequate organ function including the following:
- •a.Adequate bone marrow reserve: absolute neutrophil count (ANC) of greater than or equal to 1.5 x109/L, platelet count of greater than or equal to 100 x109/L, and haemoglobin of greater than or equal to 9 g/dL.
- •b.Hepatic: AST and ALT less than 5 x upper limit of normal (ULN); bilirubin less than 2 x ULN; in patients with obstructive jaundice and bilirubin greater than or equal 2 x ULN, internal or external biliary drainage should be performed before enrollment. Patients should be enrolled only if bilirubin declines to greater than or equal 2 x ULN.
- •c.Renal: creatinine less than 1. 5 x ULN and calculated creatinine clearance greater than or equal to 50 mL/min, calculated according to the Cockcroft formula.
- •10.Signed informed consent from patient or legal representative.
- •11.Patients available to complete study requirements (visits, tests, evaluations and follow-up procedures) in a timely manner.
- •12.Male and female patients with reproductive potential must use a reliable contraceptive method if appropriate (eg, intrauterine device [IUD], birth control pills, or barrier device) during and for 3 months after the study. Females with childbearing potential must have a negative urine pregnancy test within 7 days prior to study enrolment.
- •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 100
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Medical or psychiatric conditions that compromise the patient’s ability to give informed consent or comply with the study protocol;
- •2.Heart failure, angina pectoris or arrhythmia that are poorly controlled in spite of medication or acute myocardial infarction within 6 months preceding study enrollment;
- •3.Active infection that in the opinion of the investigator would compromise the patient’s ability to tolerate therapy, especially uncontrolled biliary tract infections;
- •4.Poorly controlled diabetes mellitus;
- •5.Interstitial lung disease
- •6.Any other serious concomitant disorders that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator;
- •7.Pregnancy or breast feeding or unwilling / unable to practice adequate contraception
- •8.Second primary malignancy (except in situ carcinoma of the cervix or adequately treated non-melanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
- •9.Pregnancy or breast feeding or unwilling / unable to practice adequate contraception.
- •10.Documented brain metastasis.
研究者
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