Clinical trial · Interventional
Procrit Versus Placebo to Determine Efficacy in Pre-Operative Major Surgical Oncology Operations
A Prospective, Randomized, Double-Blinded Control Study of Procrit Versus Placebo to Determine Efficacy in Pre-Operative Patients Undergoing Major Surgical Oncology Operations
NCT00624312CI-TRIAL-00053119withdrawnPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the effectiveness of a two-dose regimen of Procrit prior to a major surgical oncology operation.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| Procrit | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Pre-operatively randomized to Procrit
- interventionNames
- Drug: Procrit
- type
- PLACEBO_COMPARATOR
- label
- 2
- description
- Pre-operatively randomized to placebo
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Proportion of patients receiving transfusion.
- timeFrame
- One Year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.