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

October 24, 2018 updated by: M.D. Anderson Cancer Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

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

Yes

Genders Eligible for Study

All

Description

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

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: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epoetin Alfa
Drug: Procrit (epoetin alfa)
Weekly dose
Other Names:
  • Epogen
  • Erythropoietin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Patients with Reduction in Red Blood Cell Transfusions
Time Frame: 2 years
2 years
Patient Iron Levels
Time Frame: Every 4 weeks
Iron stores drawn at baseline and every four weeks.
Every 4 weeks

Collaborators and Investigators

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

Sponsor

M.D. Anderson Cancer Center

Collaborators

Ortho Pharmaceuticals

Investigators

  • Principal Investigator: Saroj Vadhan-Raj, M.D., UT MDAnderson Cancer Center

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 (Actual)

October 31, 2001

Primary Completion (Actual)

June 29, 2004

Study Completion (Actual)

June 29, 2004

Study Registration Dates

First Submitted

November 14, 2005

First Submitted That Met QC Criteria

November 14, 2005

First Posted (Estimate)

November 16, 2005

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 24, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID00-264

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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