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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00624312
• Other study ID #: 07.0048
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 2008
• Est. completion date: January 2010

Study information

• Verified date: September 2013
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Neoplasms

Intervention

Drug:
• Procrit
10 days prior to surgery - injection of 60,000 IU of Procrit Day of surgery - injection of 60,000 IU of Procrit
• Placebo
10 days prior to surgery - injection with 60,000 IU of placebo Day of surgery - injection with 60,000 IU of placebo

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	Ortho Biotech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients receiving transfusion.		One Year