Safety assessment of treatment with cetuximab in metastatic colorectal cancer patients

Safety assessment of treatment with cetuximab in metastatic colorectal cancer patients: An observational study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN34968597

Enrollment

250

Registered

2010-02-04

Start date

2009-06-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic colorectal cancer Cancer Malignant neoplasm of other and ill-defined digestive organs

Interventions

Non-interventional, observational study Patients with metastatic colorectal cancer will be treated with standard chemotherapy in combination with cetuximab, with loading dose of 400 mg/m2 and followin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Written informed consent 2. Histologically confirmed colorectal cancer 3. Diagnosis of metastatic disease 4. Age 18 to 75 years 5. ECOG performance score 0- 2 6. Life expectancy of at least 3 months 7. Adequate haematological function (ANC =1.5 x 10/9L, platelets = 100 x 10/9/L, Hb = 90g/L) 8. Adequate liver function (serum bilirubin = 1.5 x ULN, AST/ALP = 2.5 x ULN, in case of liver metastases < 5 x ULN) 9. Adequate renal function (calculated creatinine clearance = 50 mL/min)

Exclusion criteria

Exclusion criteria: 1. ECOG performance score > 2 2. Prior treatment with cetuximab 3. Participation in another clinical trial within 30 days prior to entering this study 4. Known hypersensitivity to any of the study drugs 5. Clinically significant cardiovascular disease 5.1. Myocardial infarction = 6 months before treatment start 5.2. Unstable angina 5.3. Uncontrolled hypertension 5.4. Arrhythmia requiring medication 5. Clinical evidence or confirmed brain metastases 6. Psychiatric disability to be clinically significant precluding informed consent 7. Evidence of any other disease, metabolic dysfunction or laboratory findings, which give a suspicion of a disease or condition that contraindicates the use of any investigational drugs or means a higher risk for treatment-related complications

Design outcomes

Primary

Measure	Time frame
1. Safety of treatment with cetuximab 2. Management of skin toxicity of cetuximab	—

Secondary

Measure	Time frame
1. Response rate (RECIST) 2. Progression- free survival (PFS) 3. Overall survival (OS)	—

Countries

Slovenia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026