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
Cancer patients often experience anemia due to the disease itself, chemotherapy, or both.
Quality of life is also affected, in part because of the fatigue associated with anemia.
Previous studies with epoetin alfa have suggested that achieving a higher hemoglobin level
may improve quality of life and help patients live longer. The primary objective of the
study is to demonstrate the effectiveness and safety of epoetin alfa on the reduction in red
blood cell transfusions needed in gastric and rectal cancer patients undergoing preoperative
chemotherapy and radiation therapy (chemoradiation), followed by surgery. The purpose of
this study is to assess the effectiveness of 40,000 to 60,000 Units of epoetin alfa or
matching placebo injected under the skin once weekly for up to 16 weeks (starting 1 week
before chemoradiation and extending up to 4 weeks after surgery) in reducing red blood cell
transfusions during the 16-week period. Other effectiveness measures include the ability of
epoetin alfa to maintain baseline hemoglobin levels during the chemoradiation and its effect
on quality of life and tumor response during the study period. The safety of epoetin alfa
will be assessed by incidence and severity of adverse events, clinical laboratory tests,
physical examinations, and vital signs. The hypothesis of the study is that epoetin alfa is
superior to placebo in reducing the number of transfusions, preventing anemia and improving
quality of life during chemoradiation, surgery, and immediately after surgery. 40,000 to
60,000 Units of epoetin alfa or placebo injected under the skin once weekly for up to 16
weeks. First 4 weeks the dose is 40,000 Units; increased to 60,000 Units weekly starting at
week 4 of chemoradiation if hemoglobin decreases by >=1 g/dL and/or is <=13 g/dL after 4
weeks of treatment.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Number of red blood cell transfusions
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
United States: Food and Drug Administration