Study of the Efficacy and Safety of Epoetin Alfa Administered Weekly in Patients With Gastric or Rectal Cancers Undergoing a Treatment Plan of Preoperative Chemotherapy and Radiation Therapy, Followed by Surgery

• Status: Completed
• Trial end date: 2003-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa on the reduction in red blood cell transfusions needed in gastric cancer patients and rectal cancer patients undergoing a treatment plan of preoperative chemotherapy and radiation therapy, followed by surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Collaborator: Ortho Biotech Products, L.P.
• Treatments: Epoetin Alfa

Criteria

Inclusion Criteria:

• Patients must have a confirmed diagnosis of gastric cancer or rectal cancer for whom the treatment plan is preoperative chemotherapy and radiation therapy, followed by surgery

• have a life expectancy of greater than 6 months

• have a baseline hemoglobin value of >= 10 g/dL and < 15 g/dL and adequate hematologic function

• have adequate liver and kidney function

• if female, must be postmenopausal, surgically sterile, or practicing an effective method of birth control.

Exclusion Criteria:

• Rectal cancer patients who have received chemotherapy or gastric cancer patients who have received more than two cycles of chemotherapy

• anemia due to factors other than cancer or chemotherapy (e.g., iron, vitamin B12 or folate deficiencies, hemolysis or gastrointestinal bleeding)

• history of any other major medical condition or uncontrolled disease

• had a transfusion of white blood cells or packed red blood cells within one month prior to study entry or administration of androgen (male sex hormone) therapy within 2 months of study entry

• have received prior treatment with epoetin alfa or any investigational forms of erythropoietin within the previous six months.