Contact information
Type
Scientific
Primary contact
Dr Janja Ocvirk
ORCID ID
Contact details
Zaloska 2
Ljubljana
1000
Slovenia
+386 (0)15879221
jocvirk@onko-i.si
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
01/08 at ARRS
Study information
Scientific title
Safety assessment of treatment with cetuximab in metastatic colorectal cancer patients: An observational study
Acronym
Study hypothesis
Observational study, recording skin toxicity of cetuximab according to the National Cancer Institute Common Toxicity Criteria (NCI CTC), version 3.0, and to determine the best management of skin toxicity of cetuximab
Ethics approval
The National Medical Ethics Committee, Ministry of Health, Republic of Slovenia approved on the 26th of May 2009 (ref: 215/05/09)
Study design
Single centre observational toxicity study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Metastatic colorectal cancer
Intervention
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 following weekly dose of 250 mg/m2 6 months and then according to RECIST criteria for response with maintenance therapy with cetuximab until progression of disease, unacceptable toxicity or the patient refuses further treatment. During the treatment skin toxicity of cetuximab- acneiform rash, nail changes, hypertrichosis, teleangiectasias, pruritus, paronychia, will be recorded according the National Cancer Institute Common Toxicity Criteria (NCI CTC), version 3.0.
Assessments will be performed at baseline, every week during weekly cetuximab therapy, every two weeks during maintenance therapy with cetuximab, during follow up every 3 months until the progression of disease.
The total duration of follow up will be 3 years
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Safety of treatment with cetuximab
2. Management of skin toxicity of cetuximab
Secondary outcome measures
1. Response rate (RECIST)
2. Progression- free survival (PFS)
3. Overall survival (OS)
Overall trial start date
01/06/2009
Overall trial end date
31/12/2011
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Total of 250 patients
Participant 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
Recruitment start date
01/06/2009
Recruitment end date
31/12/2011
Locations
Countries of recruitment
Slovenia
Trial participating centre
Zaloska 2
Ljubljana
1000
Slovenia
Sponsor information
Organisation
Institute of Oncology Ljubljana (Slovenia)
Sponsor details
Zaloska 2
Ljubljana
1000
Slovenia
+386 (0)15879674
jocvirk@onko-i.si
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Institute of Oncology Ljubljana (Slovenia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary