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

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

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

Conditions
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Cancer

Intervention / Treatment
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* Drug: Procrit
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Pre-operatively randomized to Procrit | Drug: Procrit<br>* 10 days prior to surgery - injection of 60,000 IU of Procrit Day of surgery - injection of 60,000 IU of Procrit<br>* Other names: Epoetin Alfa;|
| Placebo Comparator: 2<br>Pre-operatively randomized to placebo | Drug: Placebo<br>* 10 days prior to surgery - injection with 60,000 IU of placebo Day of surgery - injection with 60,000 IU of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients receiving transfusion. |  | One Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Procrit, Erythropoietin, Patients undergoing major surgical oncology operations