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

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00269997
First received: December 22, 2005
Last updated: May 17, 2011
Last verified: April 2010
  Purpose

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.


Condition Intervention Phase
Anemia
Neoplasms
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: The Effect of Subcutaneous r-HuEPO in Patients With Chronic Anemia Secondary to Cisplatin Chemotherapy

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 72
Study Completion Date: July 1990
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.

  Eligibility

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

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
  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: NCT00269997

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: NCT00269997     History of Changes
Other Study ID Numbers: CR005839
Study First Received: December 22, 2005
Last Updated: May 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Anemia
chemotherapy
epoetin alfa
epogen
erythropoietin
neoplasms
cancer

Additional relevant MeSH terms:
Anemia
Neoplasms
Hematologic Diseases
Cisplatin
Epoetin alfa
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on September 14, 2014