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.

Study Overview

• Status: Withdrawn
• Conditions: Cancer
• Intervention / Treatment: Drug: Procrit; Drug: Placebo

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.	One Year

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: Ortho Biotech, Inc.
• Investigators: Principal Investigator: Robert Martin, MD, University of Louisville

Study record dates

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: Erythropoietin; Procrit; Patients undergoing major surgical oncology operations
• Additional Relevant MeSH Terms: Neoplasms; Hematinics; Epoetin Alfa
• Other Study ID Numbers: 07.0048