A study to explore the effects of cetuximab alone or in combination with irinotecan in patients with an abnormal gene (KRAS) in their colon cancer cells.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

1. Males or females with histologically confirmed colorectal cancer;
2. Age more than 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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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