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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Ortho Biotech, Inc.
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT00624312
First received: February 15, 2008
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

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 Intervention Phase
Cancer
Drug: Procrit
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Proportion of patients receiving transfusion. [ Time Frame: One Year ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00624312

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

No publications provided

Responsible Party: Robert Martin, MD, University of Louisville
ClinicalTrials.gov Identifier: NCT00624312     History of Changes
Other Study ID Numbers: 07.0048
Study First Received: February 15, 2008
Last Updated: September 30, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014