Capecitabine, Cetuximab, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer That Cannot Be Removed By Surgery

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed adenocarcinoma of the colon or rectum
• •* Unresectable disease
• •* Metastatic or recurrent disease
• •Not amenable to potentially curative treatment
• •No untreated leptomeningeal or brain metastases
• •PATIENT CHARACTERISTICS:
• •Performance status
• •ECOG 0-2
• •Life expectancy
• •Not specified
• •Hematopoietic
• •Absolute neutrophil count ≥ 2,000/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •No known uncontrolled coagulopathy
• •Hepatic
• •AST and ALT \< 2.5 times upper limits of normal (ULN) (5 times ULN if liver metastases are present)
• •Bilirubin \< 2.0 times ULN
• •Renal
• •Creatinine clearance \> 40 mL/min
• •Urine protein negative
• •Urine protein:creatinine ratio \> 1
• •Cardiovascular
• •No unstable or uncontrolled hypertension (i.e., blood pressure \[BP\] \> 150/100 mm Hg despite antihypertensive therapy)
• •* Patients who recently started or have adjusted antihypertensive medications are eligible provided BP is \< 140/90 mm Hg for ≥ 3 different measurements over 14 days
• •No arterial thromboembolic events within the past 6 months, including any of the following:
• •* Transient ischemic attack
• •* Cerebrovascular accident
• •* Unstable angina
• •* Myocardial infarction
• •* Clinically significant peripheral vascular disease
• •No New York Heart Association class III-IV congestive heart failure
• •No uncontrolled symptomatic coronary artery disease or cardiac arrhythmia
• •No other significant uncontrolled cardiac disease
• •Gastrointestinal
• •No lack of physical integrity of the upper gastrointestinal tract
• •No malabsorption syndrome
• •No inability to tolerate oral medication
• •Immunologic
• •No prior severe infusion reaction to a monoclonal antibody
• •No history of an allergic reaction attributed to compounds of similar chemical or biologic composition to oxaliplatin, cetuximab, capecitabine, or bevacizumab
• •No prior unanticipated, severe reaction to fluoropyrimidine therapy or known hypersensitivity to fluoroucacil
• •Other
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during the study and for 3-4 months after completion of study treatment
• •No peripheral neuropathy ≥ grade 2
• •No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix
• •No known dihydropyrimidine dehydrogenase deficiency
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy
• •No prior adjuvant bevacizumab or cetuximab
• •No other concurrent anticancer immunotherapy or biologic therapy
• •Chemotherapy
• •At least 6 months since a prior adjuvant fluorouracil-, leucovorin calcium-, or capecitabine-based regimen
• •At least 12 months since prior adjuvant oxaliplatin
• •No prior chemotherapy for metastatic or recurrent disease
• •Endocrine therapy
• •No concurrent hormonal therapy
• •Radiotherapy
• •No concurrent radiotherapy
• •Surgery
• •More than 4 weeks since prior major surgery and recovered
• •More than 6 months since vascular surgery, stenting, or angioplasty
• •Other
• •At least 4 weeks since prior and no concurrent sorivudine or brivudine
• •More than 4 weeks since prior participation in any investigational drug study
• •No prior therapy that affects or targets the epidermal growth factor pathway
• •No concurrent cimetidine
• •* Concurrent ranitidine, famotidine, or proton-pump inhibitors allowed
• •Concurrent anticoagulation therapy with full-dose anticoagulant allowed provided dose is stable for at least 2 weeks