First-line Combination of Capecitabine and Oxaliplatin Plus Bevacizumab in Elderly Patients With Metastatic Colorectal Cancer

Exclusion Criteria

• •criteria
• •Previous adjuvant oxaliplatin-containing chemotherapy.
• •Previous treatment with bevacizumab.
• •Previous systemic treatment for the metastatic disease.
• •Previous radiotherapy treatment to any site within 4 weeks before the study.
• •Evidence of untreated brain metastases or spinal cord compression or primary brain tumours.
• •History or evidence upon physical examination of CNS disease unless adequately treated.
• •Symptomatic peripheral neuropathy \> 1 grade NCIC-CTG criteria.
• •Serious, non-healing wound, ulcer, or bone fracture.
• •Evidence of bleeding diathesis or coagulopathy.
• •Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy.
• •Clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents (≤6 months), myocardial infarction (≤6 months), unstable angina, New York Heart Association (NYHA) grade II or greater congestive heart failure (CHF), serious cardiac arrhythmia requiring medication.
• •Any previous venous thromboembolism \> NCI CTCAE Grade 3.
• •History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment.
• •Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.
• •Current ongoing treatment with anticoagulants for therapeutic purposes.
• •Chronic, daily treatment with high-dose aspirin (\>325 mg/day).
• •Active uncontrolled infections or other clinically relevant concomitant illness contraindicating chemotherapy administration or putting the patient at high risk for treatment-related toxicities.
• •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of localized basal and squamous cell carcinoma or cervical cancer in situ.
• •Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
• •Contraindications for the use of corticosteroids and antihistamines as premedication or known hypersensitivity to any other component of the study drugs.
• •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.