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

University of Louisville (UOFL)

Status and phase: Withdrawn; Phase 2

Conditions: Cancer

Treatments: Drug: Procrit; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00624312

07.0048

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness of a two-dose regimen of Procrit prior to a major surgical oncology operation.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Pre-operatively randomized to Procrit

Treatment:

Drug: Procrit

2

Placebo Comparator group

Description:

Pre-operatively randomized to placebo

Treatment:

Drug: Placebo