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

June 8, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 40,000 to 60,000 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. 40,000 to 60,000 Units of epoetin alfa or placebo injected under the skin once weekly for up to 16 weeks. First 4 weeks the dose is 40,000 Units; increased to 60,000 Units weekly starting at week 4 of chemoradiation if hemoglobin decreases by >=1 g/dL and/or is <=13 g/dL after 4 weeks of treatment.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of red blood cell transfusions

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Collaborators

Ortho Biotech Products, L.P.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2001

Study Completion (Actual)

December 1, 2003

Study Registration Dates

First Submitted

May 9, 2002

First Submitted That Met QC Criteria

May 9, 2002

First Posted (Estimate)

May 10, 2002

Study Record Updates

Last Update Posted (Estimate)

June 10, 2011

Last Update Submitted That Met QC Criteria

June 8, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR002365

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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