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

July 30, 2021 updated by: Robert C. Martin, University of Louisville

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients receiving transfusion.
Time Frame: One Year
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

Ortho Biotech, Inc.

Investigators

  • Principal Investigator: Robert Martin, MD, University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Anticipated)

January 1, 2010

Study Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

February 15, 2008

First Submitted That Met QC Criteria

February 26, 2008

First Posted (Estimate)

February 27, 2008

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07.0048

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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