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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.

Conditions
metastatic colorectal cancer
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
Registration Number
EUCTR2012-003638-18-GB
Lead Sponsor
Australasian Gastro-Intestinal Trials Group, Sydney University
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
All
Target Recruitment
100
Inclusion Criteria

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

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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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