EUCTR2006-003293-10-IT
Active, not recruiting
Not Applicable
A randomised, open-label Phase III study to assess efficacy and safetyof bevacizumab in combination with capecitabine as first linetreatment for elderly patients with metastatic colorectal cancer - AVEX
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- FIRST LINE METASTATIC COLORECTAL CARCINOMA
- Sponsor
- ROCHE
- Enrollment
- 430
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Written informed consent
- •Age \>\= 70 years
- •Histologically or cytologically confirmed carcinoma of the colon
- •and/or rectum
- •Diagnosis of metastatic disease not more than 6 months prior to enrolment
- •At least one measurable metastatic lesion (as per RECIST criteria)
- •Prior adjuvant (or neo\-adjuvant for rectal cancer patients)
- •chemotherapy allowed if completed more than 6 months before inclusion
- •ECOG performance score of 0 – 2
- •Live expectancy \> 3 month
Exclusion Criteria
- •Patients who received adjuvant anti\-VEGF treatment
- •Prior chemotherapeutic treatment for metastatic CRC
- •Clinical evidence of brain metastases or history or evidence upon
- •physical examination of CNS disease unless adequately treated
- •Past or current history (within the last 5 years prior to treatment
- •start) of other malignancies except metastatic colorectal cancer
- •(Patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible)
- •Clinically significant cardiovascular disease, for example CVA
- •(\<\= 6 months before treatment start), myocardial infarction (\<\= 6 months before treatment start), unstable angina, NYHA \>\= grade 2, CHF, arrhythmia requiring medication, or uncontrolled hypertension
- •Treatment with any other investigational agent, or participation
Outcomes
Primary Outcomes
Not specified
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