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

NCT00624312 | Withdrawn Phase 2 DMC

• 1 other identifier: 07.0048
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Procrit; Erythropoietin; Patients undergoing major surgical oncology operations

Outcome Measures

Primary Outcomes (1)

• Proportion of patients receiving transfusion.

  One Year

Study Arms (2)

1

ACTIVE COMPARATOR

Pre-operatively randomized to Procrit

Drug: Procrit

2

PLACEBO COMPARATOR

Pre-operatively randomized to placebo

Drug: Placebo

Interventions

Procrit DRUG

10 days prior to surgery - injection of 60,000 IU of Procrit Day of surgery - injection of 60,000 IU of Procrit

Also known as: Epoetin Alfa

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing a major surgical oncology procedure as defined below:
• Pancreatectomy
• Hepatectomy
• Esophagectomy
• Gastrectomy
• Retroperitoneal Sarcoma Resection
• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• University of Louisville: lead
• Ortho Biotech, Inc.: collaborator

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Epoetin Alfa

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Robert Martin, MD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 15, 2008
• First Posted: February 27, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: August 6, 2021

Record last verified: 2013-09

Locations

US (1)