Monitoring of treatment with bevacizumab in patients with metastatic colorectal cancer

Completed

• Conditions: Metastatic colorectal cancer; Cancer; Malignant neoplasm of other and ill-defined digestive organs

• Registration Number: ISRCTN59241668
• Lead Sponsor: Institute Of Oncology Ljubljana (Slovenia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. Written informed consent (for prospective part of the study)
2. Histologically or cytologically confirmed colorectal carcinoma with evidence of metastasis
3. Age 18 - 75 years
4. Eastern Cooperative Oncology Group (ECOG) performance score 0 - 2
5. Adequate haematological and organ function

Exclusion Criteria

1. Clinical evidence of brain metastases
2. Clinically significant cardiovascular disease. Examples:
2.1. Cerebrovascular accident (CVA) less than or equal to 6 months before treatment start
2.2. Myocardial infarction less than or equal to 6 months before treatment start
2.3. Unstable angina
2.4. New York Heart Association (NYHA) greater than or equal to grade 2 chronic heart failure (CHF)
2.5. Arrhythmia requiring medication
2.6. Uncontrolled hypertension
3. Current or recent (within 10 days prior to first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed to prophylactic) purposes
4. History of thromboembolic or haemorrhagic events within 6 months prior to treatment
5. Evidence of bleeding diathesis or coagulopathy
6. Serious, non-healing wound, ulcer, or bone fracture
7. Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to treatment
8. Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of bevacizumab or puts the patient at high risk for treatment-related complications

Study & Design

• Study Type: Observational
• Study Design: Not specified