Safety assessment of treatment with bevacizumab in metastatic colorectal cancer

ISRCTN ISRCTN36011949
DOI https://doi.org/10.1186/ISRCTN36011949
Secondary identifying numbers 1.0.10.10.2009
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

Zaloska 2
Ljubljana
1000
Slovenia

Phone +386 (0)1 587 9221
Email jocvirk@onko-i.si

Study information

Study designObservational study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleSafety assessment of treatment with bevacizumab in metastatic colorectal cancer: an observational study
Study objectivesThis 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) studiedMetastatic colorectal cancer
InterventionThis 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Bevacizumab
Primary outcome measureSafety of treatment with bevacizumab and management of toxicity, measured after each cycle of therapy
Secondary outcome measures1. 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 study start date22/03/2010
Completion date31/12/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit75 Years
SexBoth
Target number of participantsA total of 250 patients
Key inclusion criteria1. 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 criteria1. 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 enrolment22/03/2010
Date of final enrolment31/12/2011

Locations

Countries of recruitment

  • Slovenia

Study participating centre

Zaloska 2
Ljubljana
1000
Slovenia

Sponsor information

Institute of Oncology Ljubljana (Slovenia)
Research organisation

Zaloska 2
Ljubljana
1000
Slovenia

Phone +386 (0)1 587 9674
Email jocvirk@onko-i.si
Website http://www.onko-i.si/
ROR logo "ROR" https://ror.org/00y5zsg21

Funders

Funder type

Research organisation

Institute of Oncology Ljubljana (Slovenia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan