A Phase III Trial of Modified FOLFOX6 versus CAPOX, with Bevacizumab (NSC-704865) or Placebo*, as First-Line Therapy in Patients with Previously Untreated Advanced Colorectal Cancer

Histologically or cytologically documented locally advanced, recurrent or metastatic colorectal adenocarcinoma not curable by surgery or amenable to radiation therapy with curative intent; site of primary lesion confirmed to have been in large bowel; measurable or non-measurable disease; must be offered the opportunity to consent for specimen submission; no prior chemo for advanced colorectal cancer; at least 12 months must have elapsed from the time adjuvant therapy was concluded to when recurrent disease diagnosed; no prior oxaliplatin or bevacizumab; at least 28 days beyond radiation therapy; adequate renal function, liver function and bone marrow reserve; INR <= 1.5; PTT <= IULN; Zubrod <= 2; must have completed quality of life assessments if able to read and understand English; no peripheral neuropathy > Grade 1; no symptomatic pulmonary fibrosis; not pregnant or nursing; no active or uncontrolled severed infection; no uncontrolled high blood pressure, unstable angina, symptomatic congestive heart failure, recent myocardial infarction, serious uncontrolled cardiac arrhythmia; no brain or leptomeningeal disease; no other investigational agents while on protocol treatment; no contraindication to oral medications; no history of thrombotic or hemorrhagic disorders; no therapeutic anticoagulation; no full-dose aspirin use on a regular basis; no antiplatelet agents; no serious, non-healing wound, ulcer or bone fracture; must be 28 days beyond major surgery and 7 days beyond fine needle aspirations or core biopsies; no other prior malignancy except basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years; no severe acute or chronic medical or psychiatric condition or laboratory abnormality.