Xeloda and Bevacizumab to Treat Rectal Cancer

Inclusion criteria

• The patient has given written informed consent prior to any study related procedure
• Male and female aged 18 to 75 years
• ECOG performance status 0 or 1
• Histologically confirmed diagnostic of adenocarcinoma of the rectum < 15 cm from anal verge
• Clinical stage of T3, T4 with/without regional lymph node metastases, without metastatic disease
• Disease evaluable by imaging techniques
• No tumour haemorrhage in the week prior to start of study treatment
• External derivation in symptomatic occlusive tumours
• Not prior cancer treatment
• Adequate bone marrow, hepatic and renal function, defined as:

• White blood cells ≥ 4 x 109 /l
• Absolute neutrophil count ≥ 1.5 x 109 /l
• Platelets ≥ 100 x 109 /l
• Haemoglobin ≥10 g/dl
• Bilirubin < 1.25 x upper limit of normal
• Aspartate transaminase and alanine transaminase < 2.5 x upper limit of normal
• Serum creatinine ≤ 106 µmol/l
• Less than 10% weight loss

Exclusion criteria

• Rectal cancer no amenable to resection
• Any other malignancy which has been active or treated within the past 5 years , with the exception of in situ carcinoma of the cervix and non-melanoma skin lesions adequately treated
• Pregnant or breast-feeding women
• Women oh childbearing potential unless effective methods of contraception are used
• No prior or concurrent significant medical conditions, including any of the following:

• Cerebrovascular disease (including transient ischemic attack and stroke) within the past year
• Cardiovascular disease, including the following:
• Myocardial infarction within the past year
• Uncontrolled hypertension while receiving chronic medication
• Unstable angina
• New York Heart Association class II-IV congestive heart failure
• Serious cardiac arrhythmia requiring medication
• Major trauma within the past 28 days
• Serious nonhealing wound, ulcer, or bone fracture
• Evidence of bleeding diathesis or coagulopathy
• No lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication
• No evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug
• No known dihydropyrimidine dehydrogenase deficiency
• Major surgery in the 4 weeks prior to the start of study treatment
• No concurrent chronic, daily treatment with aspirin (> 325 mg/day)
• More than 10 days since prior use of full-dose oral or parenteral anticoagulants for therapeutic purposes
• No participation in another clinical trial with any investigational drug within 30 days prior to randomization or during study participation
• No other medical history or condition that, in the opinion of the investigator, would preclude study participation