Condition category
Cancer
Date applied
14/03/2010
Date assigned
09/11/2010
Last edited
09/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.onko-i.si/

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

Publication citations

Additional files

Editorial Notes