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

NCT00269997 | Completed Phase 2

• 1 other identifier: CR005839
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anemia; Neoplasms

Keywords

Anemia; chemotherapy; epoetin alfa; epogen; erythropoietin; neoplasms; cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

epoetin alfa DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead

Related Links

• A study to evaluate the safety and effectiveness of epoetin alfa given by injection beneath the skin to patients with persistent anemia as a result of cancer treatment with cisplatin, a platinum-containing anti-cancer drug

MeSH Terms

Conditions

Anemia; Neoplasms

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 22, 2005
• First Posted: December 26, 2005
• Study Completion: July 1, 1990
• Last Updated: May 18, 2011

Record last verified: 2010-04