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

NCT ID: NCT00624312

Last Updated: 2021-08-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2010-01-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Pre-operatively randomized to Procrit

Group Type: ACTIVE_COMPARATOR

Procrit

Intervention Type: DRUG

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

Day of surgery - injection of 60,000 IU of Procrit

2

Pre-operatively randomized to placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

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

Interventions

Procrit

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

Day of surgery - injection of 60,000 IU of Procrit

Intervention Type: DRUG

Placebo

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

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

Intervention Type: DRUG

Other Intervention Names

Epoetin Alfa

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho Biotech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Louisville

OTHER

Sponsor Role: lead

Responsible Party

Robert C. Martin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Martin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

University of Louisville

Louisville, Kentucky, United States

Countries

United States

Other Identifiers

07.0048

Identifier Type: -

Identifier Source: org_study_id