Randomised Phase II study of cetuximab alone or in combination with irinotecan in patients with metastatic CRC with either KRAS WT or G13D mutation.ICE CREAM: The Irinotecan Cetuximab Evaluation and the Cetuximab Response Evaluation Among Patients with G13D Mutation - ICE CREAM: AG0112CR

Australasian Gastro-Intestinal Trials Group, Sydney University0 个研究点目标入组 100 人开始时间: 2015年4月13日最近更新: 2016年8月16日

适应症

试验速览

暂无简介。

•1. Males or females with histologically confirmed colorectal cancer;
•2. Age =18 yrs;
•3. Metastatic disease not amenable to complete resection;
•4. Measurable or evaluable disease as assessed by CT scan of the chest, abdomen and pelvis as per the RECIST v1.1 criteria;
•5. Prior confirmation of tumour KRAS status as either KRAS WT (with no mutations or changes in BRAF, NRAS, PIK3CA exon20) OR KRAS G13D mutation,
•6. ECOG performance status of 0-2;
•7. Received and progressed on, or intolerant of all therapies listed below: (failure is defined as radiological progression during therapy, or toxicity limiting further therapy, or progression within 6 months of adjuvant treatment)
•- thymidylate synthase inhibitor
•- irinotecan-containing regimen
•- oxaliplatin-containing regimen, OR have documented unsuitability for an oxaliplatin-containing regimen;
•8. Adequate haematological and renal function;
•9. Adequate liver function;
•10. Life expectancy of at least 12 weeks;
•11. Study treatment both planned and able to start within 14 days of randomisation;
•12. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments;
•13. Signed, written informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 7
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 3

•1. Prior treatment with cetuximab or other drugs targeting the EGFR pathway;
•2. Severe restrictive lung disease or radiological pulmonary findings;
•3. Brain metastases that are either untreated, symptomatic, or which have not been stable for at least one month after treatment;
•4. History of another malignancy within 5 years prior to registration (exception of treated cervical carcinoma-in-situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or superficial transitional cell carcinoma of the bladder)
•5. Severe or uncontrolled cardiovascular disease;
•6. Concurrent illness;
•7. Presence of any psychological, familial, sociological or geographical condition;
•8. Pregnancy, lactation, or inadequate contraception.

发起方

Australasian Gastro-Intestinal Trials Group, Sydney University