NCT00269984

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

June 1, 1990

Completed
15.6 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 26, 2005

Completed
Last Updated

June 8, 2011

Status Verified

April 1, 2010

First QC Date

December 22, 2005

Last Update Submit

June 6, 2011

Conditions

Anemia

Keywords

AnemiaBlood transfusionEpoetin alfaErythropoietinNeoplasmEpogenCancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • 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

Interventions

Epoetin alfaDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

AnemiaNeoplasms

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

ErythropoietinColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological 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

June 1, 1990

Last Updated

June 8, 2011

Record last verified: 2010-04