Procrit Versus Placebo to Determine Efficacy in Pre-Operative Major Surgical Oncology Operations

• Status: Withdrawn
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness of a two-dose regimen of Procrit prior to a major surgical oncology operation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Louisville
• Collaborator: Ortho Biotech, Inc.
• Treatments: Epoetin Alfa

Criteria

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