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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00624312
Recruitment Status : Withdrawn
First Posted : February 27, 2008
Last Update Posted : October 1, 2013
Ortho Biotech, Inc.
Information provided by:
University of Louisville

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

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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

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00624312

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United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Ortho Biotech, Inc.
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Principal Investigator: Robert Martin, MD University of Louisville

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

Keywords provided by University of Louisville:
Patients undergoing major surgical oncology operations

Additional relevant MeSH terms:
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Epoetin Alfa