NCT00337948

Brief Summary

The purpose of this study is to determine the effectiveness and safety of epoetin alfa at a starting dose of 60,000 Units (U) once every week (QW) to a target hemoglobin (Hb) of 12 g/dL (Initiation Phase), followed by a dose of 60,000 U once every other week (Q2W) to maintain a Hb range of 11.5 to 12.5 g/dL (Maintenance Phase) in cancer patients receiving chemotherapy.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2003

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
Last Updated

June 10, 2011

Status Verified

January 1, 2011

First QC Date

June 16, 2006

Last Update Submit

June 8, 2011

Conditions

ChemotherapyAnemiaCancer

Keywords

AnemiaEpoetin AlfaChemotherapyAnemia due to Cancer

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients achieving >= 2 g/dL Hb increase from baseline or Hb >= 12 g/dL in the Initiation Phase (up to 12 weeks).

Secondary Outcomes (1)

  • Proportion of patients with: >=1 g/dL Hb increase from baseline (up to 1.9 g/dL) in the Initiation Phase; those maintaining Hb level >11 g/dL (up to 11.4 g/dL); and those maintaining Hb level 11.5 to 12.5 g/dL in the Maintenance Phase (up to 12 weeks).

Interventions

Epoetin alfaDRUG

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed diagnosis of non-myeloid malignancy and receiving chemotherapy
  • Baseline Hb of \<= 11 g/dL
  • Planned chemotherapy for a minimum of 16 weeks to be administered weekly or every 4 weeks
  • Female patients with reproductive potential must have a negative serum pregnancy test at screening.

You may not qualify if:

  • No uncontrolled hypertension or recent history (within 6 months) of uncontrolled cardiac arrhythmias, pulmonary embolism, or thrombosis
  • No transfusion of white blood cells or packed red blood cells within 28 days of Epoetin alfa treatment
  • No prior treatment with Epoetin alfa or any other erythropoetic agent within the previous three months

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
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Study Start

February 1, 2003

Study Completion

February 1, 2005

Last Updated

June 10, 2011

Record last verified: 2011-01