Contact information
Type
Scientific
Primary contact
Dr Janja Ocvirk
ORCID ID
Contact details
Zaloska 2
Ljubljana
1000
Slovenia
+386 (0)1 587 9221
jocvirk@onko-i.si
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.0.10.10.2009
Study information
Scientific title
Safety assessment of treatment with bevacizumab in metastatic colorectal cancer: an observational study
Acronym
Study hypothesis
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
The National Medical Ethics Committee at the Ministry of Health, Republic of Slovenia approved on the 21st January 2010 (ref: 115/11/09)
Study design
Observational study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Bevacizumab
Primary outcome measure
Safety of treatment with bevacizumab and management of toxicity, measured after each cycle of therapy
Secondary outcome measures
1. Response rate (RECIST), measured every 3 months
2. Progression- free survival (PFS), measured every 3 months
3. Overall survival (OS), measured every 3 months
Overall trial start date
22/03/2010
Overall trial end date
31/12/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
A total of 250 patients
Participant 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
Recruitment start date
22/03/2010
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)1 587 9674
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
Basic results (scientific)
Publication list