A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Weekly Procrit Given to Gastric or Rectal Patients

Study Overview
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Brief Summary
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To demonstrate the effectiveness of epoetin alfa on reduction in red blood cell transfusions in gastric and rectal cancer patients undergoing preoperative chemoradiation therapy followed by surgery.

Detailed Description
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Anemia and fatigue are common problems in gastric and rectal cancer subjects at the completion of chemoradiation therapy and surgery. Results of several studies in cancer subjects suggest that treatment with epoetin alfa may be effective in maintaining hemoglobin levels, thereby reducing fatigue, decreasing transfusion requirement, and potentially improving quality of life.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing Preoperative Chemoradiation Followed by Surgery

Conditions
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Gastrointestinal Cancer, Rectal Cancer

Intervention / Treatment
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* Drug: Procrit (epoetin alfa)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18 years of age or older Must have a confirmed diagnosis of gastric or rectal cancer for whom the treatment plan is preoperative chemoradiation followed by surgery Must have a baseline hemoglobin >/= 10 g/dl and < 15 g/dl Must have adequate hematologic function Must have life expectancy of more than 6 months Karnofsky performance status of at least 50% Must have adequate renal function Patients with reproductive potential must use an adequate contraceptive method during treatment and three months after completing treatment Patients must be able to read, understand, and complete the three Quality of Life questionnaires in English. Exclusion Criteria: Prior chemotherapy for patients with rectal cancer Gastric cancer patients who have received more than 2 cycles of chemotherapy Anemia due to factors other than cancer/chemotherapy Patients with prior treatment with epoetin alfa or any investigational forms of erythropoietin within the previous 6 months Known hypersensitivity to mammalian-cell derived products or to human albumin Pregnant or lactating women Untreated Central Nervous System metastases Any significant, uncontrolled disease/dysfunction of any of the major organs Uncontrolled hypertension or history of uncontrolled cardiac arrhythmias, pulmonary embolism, thrombosis New onset or poorly controlled seizures History of active second malignancy Major infection requiring hospitalization and antibiotics or surgery within 14 days of study entry Blood transfusion within 1 month of study entry Androgen therapy within 2 months of study entry

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epoetin Alfa<br> | Drug: Procrit (epoetin alfa)<br>* Weekly dose<br>* Other names: Erythropoietin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Reduction in Red Blood Cell Transfusions |  | 2 years | 
| Patient Iron Levels | Iron stores drawn at baseline and every four weeks. | Every 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epoetin Alfa, Epogen, Erythropoietin