A Study of the Effectiveness and Safety of Treatment With Epoetin Alfa on Hemoglobin Levels, Red Blood Cell Transfusions, and Quality of Life in Patients With Cancer Receiving Platinum-containing Chemotherapy

NCT00283465 | Completed Phase 4

• 1 other identifier: CR002047
• Study Type: interventional
• Target: 316
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare the effectiveness of early treatment of anemia with epoetin alfa (a glycoprotein that stimulates red blood cell production) or best standard anemia care on the need for blood transfusions, tumor response, anemia and quality of life in patients with cancer receiving platinum-containing chemotherapy.

Conditions

Anemia; Neoplasm

Keywords

Anemia; cancer; neoplasm; transfusion; quality of life; tumor response; survival; chemotherapy; hemoglobin; standard care; epoetin alfa; epoetin; erythropoietin

Outcome Measures

Primary Outcomes (1)

• Number of patients who receive an allogenic red blood cell transfusion during the study, during each chemotherapy cycle, and at 4 weeks after the last administration of chemotherapy

Secondary Outcomes (1)

• Number of units transfused during each chemotherapy cycle; change in quality of life; change in hemoglobin level; relationship between change in hemoglobin and quality of life; tumor response; patient survival up to 12 months after the end of treatment

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 having a confirmed diagnosis of cancer and are planned to receive platinum chemotherapy with a minimum of 8 weeks on study and a maximum of 6 or 12 cycles
• Eastern Cooperative Oncology Group (a scale used by researchers to represent the level of activity that a patient is capable of) score of 0 (able to carry out all normal activity without restriction) to 3 (capable of only limited self-care, confined to bed or chair \>50% of waking hours)
• life expectancy of \>=5 months
• have a hemoglobin value of \<=7.5 grams per deciliter at any time during or prior to chemotherapy

You may not qualify if:

• uncontrolled high blood pressure
• history of seizures
• untreated iron, folate, or vitamin B12 deficiency
• received androgen (e.g., testosterone) therapy within 2 months of study entry, had a major illness within 7 days of study entry, or a major infection within 1 month of study entry

Sponsors & Collaborators

• Janssen-Cilag B.V.: lead

Related Publications (1)

• Savonije JH, van Groeningen CJ, van Bochove A, Honkoop AH, van Felius CL, Wormhoudt LW, Giaccone G. Effects of early intervention with epoetin alfa on transfusion requirement, hemoglobin level and survival during platinum-based chemotherapy: Results of a multicenter randomised controlled trial. Eur J Cancer. 2005 Jul;41(11):1560-9. doi: 10.1016/j.ejca.2005.03.024.

  PMID: 15953714 RESULT

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

• Janssen-Cilag B.V. Clinical Trial

  Janssen-Cilag B.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 27, 2006
• First Posted: January 30, 2006
• Study Start: November 1, 1999
• Study Completion: April 1, 2004
• Last Updated: January 14, 2011

Record last verified: 2011-01