A Study to Evaluate the Safety and Effectiveness of Epoetin Alfa Versus Placebo in Patients With Persistent Anemia as a Result of Cancer Treatment With Cisplatin, a Platinum-containing Chemotherapy Drug

May 17, 2011 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

The Effect of Subcutaneous r-HuEPO in Patients With Chronic Anemia Secondary to Cisplatin Chemotherapy

The purpose of this study is to evaluate the safety and effectiveness of epoetin alfa versus placebo in the treatment of persistent anemia caused by advanced cancer and aggressive cisplatin chemotherapy. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients undergoing treatment with cisplatin-containing chemotherapy frequently develop significant anemia (hemoglobin <= 10.5 grams/deciliter). Agents that can increase the amount of hemoglobin in cancer patients undergoing treatment with cisplatin-containing cyclic chemotherapy may improve the patients' reduced physical strength and reduced stamina resulting from anemia, increase the patients' ability to continue chemotherapy, and improve the patients' overall qualify of life. Epoetin alfa is a genetically engineered form of a natural hormone (erythropoietin) that is used to treat anemia by stimulating red blood cell production. This is a randomized, double-blind, placebo-controlled, parallel group, multicenter study. This study evaluates the safety and effectiveness of epoetin alfa in treating patients who develop persistent anemia as a result of treatment with aggressive cisplatin-containing cyclic chemotherapy (every 3 to 4 weeks) for any cancer type (except rapid and severe onset of leukemias and malignancies of the bone marrow and spleen). The study consists of a <= 7 day screening period when patients' eligibility is determined, a 12-week double-blind treatment period, and an optional open-label treatment period. Eligible patients will be randomly assigned to one of two treatment groups: epoetin alfa 150 units/kilogram or a comparable volume of placebo, given by injection beneath the skin. Patients will be treated with study medication 3 times weekly for 12 weeks. Two of the 3 weekly doses of study medication may be self-administered by the patient at home; the patient is visited by a health professional at least once weekly to administer the other dose(s). The dose of study medication may be increased or decreased at the discretion of the physician, based on the results of blood tests. Depending on the patient's chemotherapy cycle, he or she will return to the study site every 3 or 4 weeks for administration of study medication. During the open-label treatment period, patients who choose to continue will receive 3 injections per week of epoetin alfa under the skin, until the completion of his or her chemotherapy treatments. Safety evaluations, including laboratory tests, vital signs, reporting of adverse events, physical examination, and electrocardiograms, are performed throughout the study. Effectiveness of the study drug will be determined by the number of transfusions patients require and by changes in blood test results (hemoglobin, hematocrit, and immature red blood cells) from before the start of the study to the end of the study. The study hypothesis is that epoetin alfa will, more effectively than placebo, stimulate adequate production of red blood cells to elevate the hemoglobin level in cancer patients who are anemic as a result of undergoing treatment with aggressive cisplatin-containing cyclic chemotherapy. Double-blind: Epoetin alfa 150 units/kilogram, or matching volume of placebo, injected beneath the skin 3 times weekly for 12 weeks. Open-label: Epoetin alfa at the dose received at the end of the double-blind study injected beneath the skin 3 times weekly for any remaining cycles of chemotherapy.

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

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 with cancer (except for rapid onset of severe leukemia and malignancies of the bone marrow and spleen) and having anemia resulting from cisplatin-containing chemotherapy
  • receiving cyclic chemotherapy for <=5 consecutive days every 3 or 4 weeks (for 3 cycles of chemotherapy)
  • Performance score of 0, 1, 2, or 3 (grades assessing patients' ability to perform daily activities)
  • having a life expectancy of at least 3 months
  • having a hemoglobin level <= 10.5 grams/deciliter, and signs and symptoms of physical stability for 1 month before the study (based on physical examination including vital signs, weight, and electrocardiogram)
  • with an ability to administer self-injections

Exclusion Criteria:

  • Patients with a history of any blood disease
  • having signs and symptoms of significant disease/dysfunction not caused by the underlying cancer
  • receiving radiation therapy or surgery to decrease the number of cancer cells within 30 days before the start of the study
  • having a sudden and severe onset of illness within 7 days before the start of the study
  • having cancer that has spread to the brain, a history of seizures, uncontrolled high blood pressure, or an iron, folate, or vitamin B12 deficiency

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 transfusions required; Changes in hemoglobin, hematocrit, and reticulocyte (immature red blood cells) levels from before the study to the end of the study

Secondary Outcome Measures

Outcome Measure
Quality of life assessment; Physician's global evaluation; Performance score (ability to perform daily activities); Assessment of safety (laboratory tests, vital signs, and adverse events) from before the study to the end of the study

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.

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 Completion (Actual)

July 1, 1990

Study Registration Dates

First Submitted

December 22, 2005

First Submitted That Met QC Criteria

December 22, 2005

First Posted (Estimate)

December 26, 2005

Study Record Updates

Last Update Posted (Estimate)

May 18, 2011

Last Update Submitted That Met QC Criteria

May 17, 2011

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR005839

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.

Clinical Trials on Neoplasms

Clinical Trials on epoetin alfa

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe