NCT00254436

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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.

Conditions

• Gastrointestinal Cancer
• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Procrit (epoetin alfa)	Weekly dose

Timeline

• Start date: 2001-10-31
• Primary completion: 2004-06-29
• Completion: 2004-06-29
• First posted: 2005-11-16
• Last updated: 2018-10-25

Locations

1 site across 1 country: United States