Safety assessment of treatment with cetuximab in metastatic colorectal cancer patients

Completed

• Conditions: Metastatic colorectal cancer; Cancer; Malignant neoplasm of other and ill-defined digestive organs

• Registration Number: ISRCTN34968597
• Lead Sponsor: Institute of Oncology Ljubljana (Slovenia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Safety of treatment with cetuximab <br>2. Management of skin toxicity of cetuximab

Secondary Outcome Measures

Name	Time	Method
1. Response rate (RECIST)<br>2. Progression- free survival (PFS)<br>3. Overall survival (OS)