Safety assessment of treatment with bevacizumab in metastatic colorectal cancer
| ISRCTN | ISRCTN36011949 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN36011949 |
| Protocol serial number | 1.0.10.10.2009 |
| Sponsor | Institute of Oncology Ljubljana (Slovenia) |
| Funder | Institute of Oncology Ljubljana (Slovenia) |
- Submission date
- 14/03/2010
- Registration date
- 09/11/2010
- Last edited
- 09/11/2010
- 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)1 587 9221 |
|---|---|
| jocvirk@onko-i.si |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Safety assessment of treatment with bevacizumab in metastatic colorectal cancer: an observational study |
| Study objectives | This is an observational study recording bevacizumab toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.02 and the management of toxicity. |
| Ethics approval(s) | The National Medical Ethics Committee at the Ministry of Health, Republic of Slovenia approved on the 21st January 2010 (ref: 115/11/09) |
| Health condition(s) or problem(s) studied | Metastatic colorectal cancer |
| Intervention | This is a non-interventional, observational study. Patients with metastatic colorectal cancer will be treated with standard chemotherapy in combination with bevacizumab, with a dose of 5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks in first-line therapy, and 10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks in second-line therapy for 6 months and then according to RECIST criteria for response with maintenance therapy with bevacizumab until progression of disease, unaccetable toxicity or the patient refuses further treatment. During the treatment toxicity of bevacizumab, hypertension, proteinuria, haemorrhage, venous thrombosis, gastrointestinal perforation, hypersensitivity reaction, will be recorded according the Common Terminology Criteria for Adverse Events (CTCAE), version 4.02. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bevacizumab |
| Primary outcome measure(s) |
Safety of treatment with bevacizumab and management of toxicity, measured after each cycle of therapy |
| Key secondary outcome measure(s) |
1. Response rate (RECIST), measured every 3 months |
| Completion date | 31/12/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 75 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. Aged 18 to 75 years, either sex 5. Eastern Cooperative Oncology Group (ECOG) performance score 0 - 2 6. Life expectancy of at least 3 months 7. Adequate haematological function (absolute neutrophil count [ANC] greater than or equal to 1.5 x 10^9 L, platelets greater than or equal to 100 x 10^9 L, haemoglobin [Hb] greater than or equal to 90 g/L) 8. Adequate liver function (serum bilirubin less than or equal to 1.5 x upper limit of normal [ULN], aspartate aminotransferase [AST]/alkaline phosphatase [ALP] less than or equal to 2.5 x ULN, in case of liver metastases less than 5 x ULN) 9. Adequate renal function (calculated creatinine clearance greater than or equal to 50 mL/min) |
| Key exclusion criteria | 1. ECOG performance score greater than 2 2. Participation in another clinical trial within 30 days prior to entering this study 3. Known hypersensitivity to any of the study drugs 4. Clinically significant cardiovascular disease (myocardial infarction less than or equal to 6 months before treatment start, unstable angina, uncontrolled hypertension, arrhythmia requiring medication) 5. Known coagulopathy 6. Proteinuria greater than 500 mg/24 hours 7. Chronic use of full dose oral or parenteral anticoagulants 8. High dose of aspirin (greater than 325 mg/day) 9. Anti-platelet drugs or known bleeding diathesis 10. Psychiatric disability to be clinically significant precluding informed consent 11. Evidence of any other disease 12. Metabolic dysfunction or laboratory findings that 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 | 22/03/2010 |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
