A Study to Determine the Safety and Effectiveness of Epoetin Alfa Versus Placebo in Patients With Persistent Anemia Caused by Advanced Cancer

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00269984
First received: December 22, 2005
Last updated: June 6, 2011
Last verified: April 2010
  Purpose

The purpose of this study is to determine the safety and effectiveness of epoetin alfa versus placebo, injected beneath the skin, in the treatment of patients with persistent anemia caused by advanced cancer, with a below normal hematocrit of <= 37%. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.


Condition Intervention Phase
Anemia
Drug: Epoetin alfa
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study With Open-Label Follow-Up to Determine the Safety and Efficacy of r-HuEPO, Administered Subcutaneously, in Chronic Anemia Induced by Advanced Cancer

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Changes in hemoglobin, hematocrit, and reticulocyte (immature red blood cells) count from before the study to the end of the study

Secondary Outcome Measures:
  • Safety assessment (laboratory tests, vital signs, adverse events, physical examination, electrocardiogram) from before study to end of double-blind study and to the end of open-label study; Physician's global evaluation; Quality of life assessment

Enrollment: 56
Study Completion Date: June 1990
Detailed Description:

Patients with advanced cancer frequently develop significant anemia, as determined by a blood test to measure hematocrit, with a below normal hematocrit of <=37%. Agents that can elevate the hematocrit level in patients with advanced cancer may increase the physical strength and stamina that is decreased by anemia, increase the patients' ability to persevere with chemotherapy, and improve their overall quality 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 to determine the safety and effectiveness of treatment with epoetin alfa in patients with persistent anemia caused by advanced cancer. Eligible patients will be randomly assigned to one of two treatment groups: epoetin alfa 100 units per kilogram or a comparable volume of placebo, given by injection beneath the skin. Patients will be given study medication 3 times weekly for up to 8 weeks or until a patient's hematocrit reaches 38% to 40%. The 8 weeks will be decreased to 4 weeks if, by Week 4, a patient's hematocrit decreases by more than 15% from the start of the study. At the end of the double-blind part of the study, patients who achieved a hematocrit level of 38 to 40%, or whose hematocrit decreased by >=15% from the start of the study by Week 4, will be allowed to enroll in the open-label part of the study for an additional 6 months and will receive epoetin alfa at a dose adjusted to maintain a hematocrit level between 38% and 40%. Within 5 to 7 days after it is documented that a patient's hematocrit has reached 38% to 40%, epoetin alfa will then be given once weekly by injection beneath the skin to maintain the hematocrit between 38% and 40% for the remaining time of the study. Patients will be seen by a healthcare professional once weekly and by the physician once monthly. Safety evaluations will include changes in laboratory tests, vital signs, physical examinations, electrocardiograms, and the incidence of adverse events from the start of the study to the end of the double-blind part of the study and to the end of the open-label part of the study. Effectiveness will be assessed by blood transfusion requirements and changes in hemoglobin, hematocrit, and immature red blood cell count from the start of the study to the end of study, as well as the physician's global evaluation and the quality of life assessment at the end of the double-blind part of the study and at the end of the open-label part of the study. The study hypothesis is that epoetin alfa will be well tolerated and more effective than placebo in stimulating adequate production of red blood cells in patients who are anemic as a result of advanced cancer. Double-blind: Epoetin alfa 100 units/kilogram (U/kg) or placebo injected under the skin; given 3 times weekly for 8 weeks or until hematocrit reaches 38%-40%. Open-label: Epoetin alfa 100 or 150 U/kg or a higher dose injected under the skin on a schedule to maintain hematocrit of 38%-40%.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with advanced cancer (except for rapid onset of severe leukemia and malignancies of the bone marrow and spleen) which is resistant to treatment or cure with chemotherapy or for which there is no established effective chemotherapy
  • having persistent anemia as determined by a low hematocrit of <=37% and a negative direct Coombs' test (a blood test used to detect proteins and especially certain antibodies produced abnormally by some cancer cells on the surface of red blood cells)
  • having a Performance score of 0, 1, 2, or 3 (patients' ability to perform daily activities, a score ranging from 0 [fully active, no disease restriction] to 3 [capable of only limited self-care, confined to bed or chair more than 50% of waking hours])
  • having a life expectancy of at least 3 months
  • who have not had chemotherapy to decrease cells and or radiation therapy within 1 month before the start of the study

Exclusion Criteria:

  • Patients who have a history of any primary blood disease
  • having signs and symptoms of significant disease/dysfunction not caused by the underlying cancer
  • having an iron, folate, or vitamin B12 deficiency, or signs and symptoms suggestive of an autoimmune disease causing blood to break down and release iron-containing pigment
  • having significant bleeding of the stomach and/or intestines, uncontrolled high blood pressure, a history of seizures, or a sudden onset of severe illness within 7 days before the start of the study
  • received androgen therapy within 2 months before the start of the study or have used medications known to affect the hematocrit within 1 month before the start of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269984

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00269984     History of Changes
Other Study ID Numbers: CR005833
Study First Received: December 22, 2005
Last Updated: June 6, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Anemia
Blood transfusion
Epoetin alfa
Erythropoietin
Neoplasm
Epogen
Cancer

Additional relevant MeSH terms:
Anemia
Hematologic Diseases
Epoetin alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014