A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Weekly Procrit Given to Gastric or Rectal Patients
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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.
Condition or disease
Gastrointestinal CancerRectal Cancer
Drug: Procrit (epoetin alfa)
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.
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
Study Start Date
Actual Primary Completion Date
Actual Study Completion Date
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
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