A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Weekly Procrit Given to Gastric or Rectal Patients
Gastrointestinal Cancer, Rectal Cancer
About this trial
This is an interventional treatment trial for Gastrointestinal Cancer focused on measuring Epoetin Alfa, Epogen, Erythropoietin
Eligibility Criteria
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
Sites / Locations
- UT MD Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Epoetin Alfa