Safety assessment of treatment with cetuximab in metastatic colorectal cancer patients
| ISRCTN | ISRCTN34968597 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34968597 |
| Protocol serial number | 01/08 at ARRS |
| Sponsor | Institute of Oncology Ljubljana (Slovenia) |
| Funder | Institute of Oncology Ljubljana (Slovenia) |
- Submission date
- 26/01/2010
- Registration date
- 04/02/2010
- Last edited
- 04/02/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Janja Ocvirk
Scientific
Scientific
Zaloska 2
Ljubljana
1000
Slovenia
| Phone | +386 (0)15879221 |
|---|---|
| jocvirk@onko-i.si |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single centre observational toxicity study |
| Secondary study design | Cohort study |
| Scientific title | Safety assessment of treatment with cetuximab in metastatic colorectal cancer patients: An observational study |
| Study objectives | 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(s) | The National Medical Ethics Committee, Ministry of Health, Republic of Slovenia approved on the 26th of May 2009 (ref: 215/05/09) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Safety of treatment with cetuximab |
| Key secondary outcome measure(s) |
1. Response rate (RECIST) |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 250 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/06/2009 |
| Date of final enrolment | 31/12/2011 |
Locations
Countries of recruitment
- Slovenia
Study participating centre
Zaloska 2
Ljubljana
1000
Slovenia
1000
Slovenia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
