Safety assessment of treatment with bevacizumab in metastatic colorectal cancer

Completed

• Conditions: Metastatic colorectal cancer; Cancer; Malignant neoplasm of rectosigmoid junction

• Registration Number: ISRCTN36011949
• Lead Sponsor: Institute of Oncology Ljubljana (Slovenia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 250

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)

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of treatment with bevacizumab and management of toxicity, measured after each cycle of therapy

Secondary Outcome Measures

Name	Time	Method
1. Response rate (RECIST), measured every 3 months<br>2. Progression- free survival (PFS), measured every 3 months<br>3. Overall survival (OS), measured every 3 months