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

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ClinicalTrials.gov Identifier: NCT00624312
Recruitment Status : Withdrawn
First Posted : February 27, 2008
Last Update Posted : October 1, 2013
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by:
University of Louisville

February 15, 2008
February 27, 2008
October 1, 2013
February 2008
January 2010   (Final data collection date for primary outcome measure)
Proportion of patients receiving transfusion. [ Time Frame: One Year ]
Same as current
Complete list of historical versions of study NCT00624312 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Procrit Versus Placebo to Determine Efficacy in Pre-Operative Major Surgical Oncology Operations
A Prospective, Randomized, Double-Blinded Control Study of Procrit Versus Placebo to Determine Efficacy in Pre-Operative Patients Undergoing Major Surgical Oncology Operations
The purpose of this study is to evaluate the effectiveness of a two-dose regimen of Procrit prior to a major surgical oncology operation.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Cancer
  • 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
  • Drug: Placebo

    10 days prior to surgery - injection with 60,000 IU of placebo

    Day of surgery - injection with 60,000 IU of placebo

  • Active Comparator: 1
    Pre-operatively randomized to Procrit
    Intervention: Drug: Procrit
  • Placebo Comparator: 2
    Pre-operatively randomized to placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
86
January 2010
January 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00624312
07.0048
Yes
Not Provided
Not Provided
Robert Martin, MD, University of Louisville
University of Louisville
Ortho Biotech, Inc.
Principal Investigator: Robert Martin, MD University of Louisville
University of Louisville
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP