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

Phase 2

Withdrawn

• Conditions: Cancer
• Interventions: Drug: Placebo; Drug: Procrit

• Registration Number: NCT00624312
• Lead Sponsor: University of Louisville

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-15
• Study First Submitted QC: 2008-02-26
• Study First Posted: 2008-02-27
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2013-09
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	Pre-operatively randomized to placebo
1	Procrit	Pre-operatively randomized to Procrit

Primary Outcome Measures

Name	Time	Method
Proportion of patients receiving transfusion.	One Year

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States