Bevacizumab and Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the colon or rectum

  • Previously untreated metastatic disease

• Measurable disease by RECIST

  • Must not be located in a prior radiation field
• No cerebral or meningeal metastases

PATIENT CHARACTERISTICS:

Inclusion criteria:

• WHO performance status 0-1
• Life expectancy > 12 weeks
• Absolute neutrophil count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Transaminases ≤ 2 times ULN (5 times ULN if liver metastases present)
• Alkaline phosphatase ≤ 2 times ULN (5 times ULN if liver metastases present)
• Creatinine ≤ 130 μmol/L OR creatinine clearance ≥ 30 mL/min
• Proteinuria < 2+ or urine protein ≤ 1 g/24 hours
• Not pregnant or nursing
• Fertile patients of must use effective contraception

Exclusion criteria:

• Uncontrolled cardiac disease
• Prior cerebral vascular accident
• Uncontrolled arterial hypertension
• Severe renal or hepatic insufficiency
• Prior arteriopathy
• Bleeding disorder or nonhealing wound
• Coagulopathy
• Other malignancy within the past 2 years except basal cell or squamous cell skin cancer or curatively treated carcinoma of the cervix
• Psychiatric disorder compromising comprehension or participation in the study
• Intestinal occlusion or subocclusion not caused by medical therapy

PRIOR CONCURRENT THERAPY:

Inclusion criteria:

• See Disease Characteristics

Exclusion criteria:

• Prior adjuvant bevacizumab or irinotecan hydrochloride
• Concurrent aspirin (> 325 mg/day) or therapeutic anticoagulants
• Surgery in the past 28 days