Procrit Versus Placebo to Determine Efficacy in Pre-Operative Major Surgical Oncology Operations
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 1 Pre-operatively randomized to Procrit |
Drug: Procrit
10 days prior to surgery - injection of 60,000 IU of Procrit
Day of surgery - injection of 60,000 IU of Procrit
Other Names:
|
| Placebo Comparator: 2 Pre-operatively randomized to placebo |
Drug: Placebo
10 days prior to surgery - injection with 60,000 IU of placebo
Day of surgery - injection with 60,000 IU of placebo
|
Outcome Measures
Primary Outcome Measures
- Proportion of patients receiving transfusion. [One Year]
Eligibility Criteria
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
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History of spontaneous venous thrombotic vascular events
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Louisville | Louisville | Kentucky | United States | 40202 |
Sponsors and Collaborators
- University of Louisville
- Ortho Biotech, Inc.
Investigators
- Principal Investigator: Robert Martin, MD, University of Louisville
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 07.0048