Capecitabine, Oxaliplatin, and Bevacizumab in Treating Patients With Metastatic or Recurrent Colorectal Cancer

This is an interventional treatment trial for Colorectal Cancer focused on measuring adenocarcinoma of the colon, recurrent colon cancer, stage IV colon cancer, adenocarcinoma of the rectum, recurrent rectal cancer, stage IV rectal cancer Read More

DISEASE CHARACTERISTICS:

• Histologically documented adenocarcinoma of the colon or rectum

  • Metastatic or recurrent disease not amenable to potentially curative treatment (e.g., inoperable metastatic disease)
• No leptomeningeal or brain metastases

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2
• Absolute neutrophil count ≥ 2,000/mm^3
• Platelet count ≥ 100,000/mm^3
• AST/ALT < 2.5 times upper limit of normal (ULN) (5 times ULN if known liver metastases)
• Bilirubin < 1.5 times ULN
• Creatinine clearance > 50 mL/min

• No unstable or poorly controlled hypertension (> 150/100 mm Hg)

  • Patients who have recently started or adjusted antihypertensive medications are eligible provided blood pressure is < 140/90 mm Hg on any new regimen for at least 3 different observations over 14 days
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during study and for at least 3-4 months after study completion
• No arterial or venous thrombosis (including cerebrovascular accident) within the last 3 months
• No known, existing, uncontrolled coagulopathy
• No clinically significant cardiac disease
• No congestive heart failure
• No symptomatic coronary artery disease
• No cardiac arrhythmias not well controlled with medication
• No myocardial infarction within the last 12 months
• No history of allergic reactions attributed to compounds of similar chemical or biologic composition to oxaliplatin, capecitabine, or bevacizumab
• No history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications

PRIOR CONCURRENT THERAPY:

• At least 4 weeks since prior sorivudine or brivudine
• At least 6 months since prior adjuvant treatment with fluorouracil and leucovorin calcium or a fluorouracil and leucovorin calcium-based regimen
• No major surgery within 4 weeks without complete recovery
• No prior chemotherapy for metastatic/recurrent disease
• No cancer immunotherapy or other biologic therapy while on therapy
• No radiotherapy while on study
• No hormonal therapy for cancer while on study
• No full-dose warfarin (INR of > 1.5), heparin (> 10,000 units/day), or thrombolytic agents
• Allopurinol and cimetidine should be discontinued prior to starting on this regimen