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
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
1 other identifier
interventional
60
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2001
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
May 9, 2002
CompletedFirst Posted
Study publicly available on registry
May 10, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2003
CompletedJune 10, 2011
April 1, 2010
May 9, 2002
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of red blood cell transfusions
Secondary Outcomes (1)
Hemoglobin levels during preoperative chemoradiation; effect on quality of life measured by patient self-reported Linear Analog Scale Assessment, Functional Assessment of Cancer Therapy-Anemia, and Brief Fatigue Inventory; tumor response; safety
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 9, 2002
First Posted
May 10, 2002
Study Start
December 1, 2001
Study Completion
December 1, 2003
Last Updated
June 10, 2011
Record last verified: 2010-04