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

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Cancer	Drug: Procrit; Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	0 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Prevention
Official Title:	A Prospective, Randomized, Double-Blinded Control Study of Procrit Versus Placebo to Determine Efficacy in Pre-Operative Patients Undergoing Major Surgical Oncology Operations
Study Start Date :	February 2008
Estimated Primary Completion Date :	January 2010
Estimated Study Completion Date :	January 2010

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: 1; Pre-operatively randomized to Procrit	Drug: Procrit; 10 days prior to surgery - injection of 60,000 IU of Procrit Day of surgery - injection of 60,000 IU of Procrit; Other Name: Epoetin Alfa
Placebo Comparator: 2; Pre-operatively randomized to placebo	Drug: Placebo; 10 days prior to surgery - injection with 60,000 IU of placebo Day of surgery - injection with 60,000 IU of placebo

Outcome Measures

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Primary Outcome Measures :

1. Proportion of patients receiving transfusion. [ Time Frame: One Year ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202

Sponsors and Collaborators

University of Louisville

Ortho Biotech, Inc.

Investigators

Principal Investigator:	Robert Martin, MD	University of Louisville

More Information

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Responsible Party:	Robert Martin, MD, University of Louisville
ClinicalTrials.gov Identifier:	NCT00624312 History of Changes
Other Study ID Numbers:	07.0048
First Posted:	February 27, 2008
Last Update Posted:	October 1, 2013
Last Verified:	September 2013

Keywords provided by University of Louisville:

Procrit; Erythropoietin; Patients undergoing major surgical oncology operations

Additional relevant MeSH terms:

Epoetin Alfa; Hematinics