Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036400
Status:
COMPLETED
Last Update Posted:
2011-06-10
First Post:
2002-05-09
Brief Title:
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
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
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:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
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 40000 to 60000 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 40000 to 60000 Units of epoetin alfa or placebo injected under the skin once weekly for up to 16 weeks First 4 weeks the dose is 40000 Units increased to 60000 Units weekly starting at week 4 of chemoradiation if hemoglobin decreases by 1 gdL andor is 13 gdL after 4 weeks of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None