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

• Status: Terminated
• Trial end date: 2004-06-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Ortho Pharmaceuticals
• Treatments: Epoetin Alfa

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