A Prospective, Randomized, Double-Blinded Control Study of Procrit Versus Placebo to Determine Efficacy in Pre-Operative Patients Undergoing Major Surgical Oncology Operations

Inclusion Criteria:

- Undergoing a major surgical oncology procedure as defined below:

- Pancreatectomy

- Hepatectomy

- Esophagectomy

- Gastrectomy

- Retroperitoneal Sarcoma Resection

- 18 years of age and older

- Hemoglobin level of ≥ 10g/dL to < 13g/dL, within 10 days of enrollment

- If female of child-bearing potential, negative pregnancy test within 14 days prior to
surgery

- If subject is a sexually active male or a sexually active female of child- bearing
potential, subject agrees to use a medically accepted form of contraception from the
time of enrollment to completion of all follow-up study visits

- IRB-approved informed consent, signed by the subject or the subject's legally
authorized representative ≥ 18 years of age

Exclusion Criteria:

- Pre-operative hemoglobin level ≥ 13g/dL or < 10g/dL

- Uncontrolled hypertension (defined as a systolic pressure ≥ 160 and/or a diastolic
pressure ≥ 110)

- History of allergy to Procrit®

- Known hypersensitivity to mammalian cell-derived products or human albumin

- History of spontaneous venous thrombotic vascular events

- Anemia due to factors other than cancer,(e.g. iron deficiency, B12 deficiency)

- History of (within 12 months) deep venous thrombosis (DVT), pulmonary embolus (PE),
or other venous thrombotic events. Prior superficial thrombophlebitis is not an
exclusion criterion

- History of (within 6 months) uncontrolled cardiac arrhythmias, cerebrovascular
accident (CVA), transient ischemic attack (TIA), acute coronary syndrome (ACS), or
other arterial thrombosis. ACS includes Unstable Angina, Q wave Myocardial Infarction
(QwMI), and non-Q wave myocardial infarction (NQMI)

- Currently receiving therapeutic or prophylactic anticoagulants for conditions other
than planned surgery. The only exceptions are low dose aspirin (≤ 325 mg/day) or low
dose anticoagulant to maintain patency of intravenous (IV) lines

- Patient is a candidate for autologous blood transfusion