A Study of PRO95780 Administered in Combination With the FOLFOX Regimen and Bevacizumab in Patients With Previously Untreated, Locally Advanced, Recurrent, and Metastatic Colorectal Cancer (APM4566g)

Inclusion criteria

• Histologically confirmed CRC with evidence of locally advanced recurrent or metastatic disease and measurable tumor lesions
• Life expectancy > 3 months
• For patients of reproductive potential (males and females), use of reliable means for contraception throughout the trial and for 6 months following their final exposure to study treatment
• Willingness and capability to be accessible for study follow-up

Exclusion criteria

• Prior 5-FU, capecitabine, and/or oxaliplatin treatment with the exception of: prior oxaliplatin treatment≤ 6 weeks in the advanced or metastatic setting; prior treatment with 5-FU, capecitabine, and/or oxaliplatin in the adjuvant setting if relapse occurred > 6 months from concluding adjuvant therapy
• Peripheral neuropathy Grade ≥ 2
• Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy
• Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1, or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to Cycle 1, Day 1
• Chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to Cycle 1, Day 1
• Evidence of clinically detectable ascites
• Other invasive malignancies within 5 years prior to Cycle 1, Day 1
• History or evidence upon physical examination of active central nervous system (CNS) disease
• Current or recent participation in another experimental drug study
• Clinically significant cardiovascular disease, New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia within 1 year prior to Cycle 1, Day 1, or Grade II or greater peripheral vascular disease
• Active infection requiring parenteral antibiotics
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Cycle 1, Day 1, fine needle aspirations within 7 days prior to Cycle 1, Day 1, or anticipation of need for major surgical procedure during the course of the study
• Known or suspected to be positive for the human immunodeficiency virus (HIV)
• Known to be positive for hepatitis C or hepatitis B surface antigen
• Inadequately controlled hypertension
• Prior history of hypertensive crisis or hypertensive encephalopathy
• History of arterial thromboembolic event 6 months prior to Cycle 1, Day 1
• History of abdominal fistula or gastrointestinal perforation within 6 months prior to Cycle 1, Day 1
• Bleeding diathesis or coagulopathy
• Pregnancy (positive pregnancy test) or breast feeding
• Serious, non-healing wound, ulcer, or bone fracture