Combination Chemotherapy and Bevacizumab in Treating Patients With Locally Advanced, Metastatic, or Recurrent Colorectal Cancer

Inclusion Criteria

• •Histologically or cytologically confirmed locally advanced, recurrent, or metastatic colorectal adenocarcinoma
• •* Not curable by surgery or amenable to radiotherapy with curative intent
• •* Previously resected colorectal cancer with new evidence of metastasis does not require separate histologic or cytologic confirmation unless one of the following is true:
• •* More than 5 years has elapsed between primary surgery and development of metastatic disease
• •* Primary tumor was T1-T2, N0, M0
• •Site of primary lesion must be or have been in the large bowel as determined by endoscopy, radiology, or surgery
• •Measurable or evaluable disease
• •No known brain or leptomeningeal disease
• •Performance status - Zubrod 0-2
• •No history of hemorrhagic or thrombotic disorders
• •Absolute neutrophil count greater than 1,500/mm\^3
• •Platelet count greater than 100,000/mm\^3
• •Bilirubin no greater than 2.0 times upper limit of normal (ULN)
• •SGOT no greater than 2.5 times ULN (5 times ULN for patients with liver involvement)
• •Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN for patients with liver involvement or 10 times ULN for patients with bone involvement)
• •INR no greater than 1.5
• •PTT no greater than ULN
• •Creatinine no greater than 1.5 times ULN
• •Creatinine clearance at least 50 mL/min
• •Proteinuria less than 1+\*
• •Protein less than 500mg/24 hours\*
• •No uncontrolled hypertension
• •* Hypertension must be well-controlled (i.e., less than 160/90) and on a stable regimen of antihypertensive therapy
• •No unstable angina
• •No symptomatic congestive heart failure
• •No myocardial infarction within the past 6 months
• •No serious uncontrolled cardiac arrhythmia
• •No New York Heart Association class III or IV heart disease
• •No symptomatic pulmonary fibrosis
• •Not pregnant or nursing
• •Fertile patients must use effective contraception
• •No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
• •No active or uncontrolled severe infection
• •No contraindication to oral medications (e.g., severe dysphagia)
• •* G-tubes or J-tubes allowed
• •No peripheral neuropathy greater than grade 1
• •No serious non-healing wound, ulcer, or bone fracture
• •No significant traumatic injury within the past 28 days
• •No other severe acute or chronic medical condition or laboratory abnormality that would preclude study participation
• •No psychiatric condition that would preclude study participation
• •No prior bevacizumab
• •No prior oxaliplatin
• •No prior chemotherapy for advanced colorectal cancer
• •* Prior adjuvant therapy for resected stage II-III disease allowed provided at least 12 months have elapsed between completion of therapy and diagnosis of recurrent disease
• •At least 28 days since prior radiotherapy and recovered
• •See Disease Characteristics
• •More than 28 days since prior major surgical procedure or open biopsy
• •More than 7 days since prior fine needle aspiration or core biopsy
• •No concurrent major surgery
• •More than 10 days since prior full-dose aspirin (325 mg)
• •No concurrent antiplatelet agents (e.g., dipyridamole, ticlopidine, clopidogrel, or cilostazol)
• •No other concurrent investigational agents
• •No concurrent therapeutic anticoagulation
• •* Prophylactic anticoagulation of central venous lines allowed
• •* Low-dose prophylactic enoxaparin or heparin allowed
• •No concurrent cimetidine
• •No concurrent sorivudine or its related analogs (e.g., brivudine)
• •No concurrent use of a cold cap or iced mouth rinses