Status:
WITHDRAWN
Procrit Versus Placebo to Determine Efficacy in Pre-Operative Major Surgical Oncology Operations
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
Ortho Biotech, Inc.
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00624312
Start Date
February 1 2008
End Date
January 1 2010
Last Update
August 6 2021
Active Locations (1)
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1
University of Louisville
Louisville, Kentucky, United States, 40202