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

Primary Purpose

Gastrointestinal Cancer, Rectal Cancer

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Procrit (epoetin alfa)
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Cancer focused on measuring Epoetin Alfa, Epogen, Erythropoietin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UT MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epoetin Alfa

Arm Description

Outcomes

Primary Outcome Measures

Number of Patients with Reduction in Red Blood Cell Transfusions
Patient Iron Levels
Iron stores drawn at baseline and every four weeks.

Secondary Outcome Measures

Full Information

First Posted
November 14, 2005
Last Updated
October 24, 2018
Sponsor
M.D. Anderson Cancer Center
Collaborators
Ortho Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00254436
Brief Title
A Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Weekly Procrit Given to Gastric or Rectal Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Study Start Date
October 31, 2001 (Actual)
Primary Completion Date
June 29, 2004 (Actual)
Study Completion Date
June 29, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
Ortho Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer, Rectal Cancer
Keywords
Epoetin Alfa, Epogen, Erythropoietin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epoetin Alfa
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Procrit (epoetin alfa)
Other Intervention Name(s)
Epogen, Erythropoietin
Intervention Description
Weekly dose
Primary Outcome Measure Information:
Title
Number of Patients with Reduction in Red Blood Cell Transfusions
Time Frame
2 years
Title
Patient Iron Levels
Description
Iron stores drawn at baseline and every four weeks.
Time Frame
Every 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saroj Vadhan-Raj, M.D.
Organizational Affiliation
UT MDAnderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
UT MD Anderson Cancer Center website

Learn more about this trial

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

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