NCT00210730

Brief Summary

The purpose of this study is to compare the efficacy of epoetin alfa (PROCRIT®) administered subcutaneously (sc) once every week (qw) vs. no epoetin alfa (PROCRIT®) treatment in patients with cancer who are anemic.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jun 2004

Shorter than P25 for phase_3

Status
terminated

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

June 1, 2004

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

June 10, 2011

Status Verified

March 1, 2010

First QC Date

September 13, 2005

Last Update Submit

June 8, 2011

Conditions

Anemia

Keywords

AnemiaNeoplasmHemoglobin Level

Outcome Measures

Primary Outcomes (1)

  • The primary efficacy endpoint is hematologic response, defined as follows: Transfusion free during study, and the average of post baseline Hb values > 11 g/dL without a post baseline Hb < 10 g/dL.

Secondary Outcomes (1)

  • Proportion of patients transfused, time to first transfusion, proportion of patients with two post baseline Hb values > 12 g/dL, mean final Hb, mean lowest Hb, proportion of patients with Hb < 10, weekly Hb, QOL

Interventions

epoetin alfaDRUG

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed diagnosis of non-myeloid malignancy
  • Baseline hemoglobin value \>= 11 g/dL and \<= 12 g/dL unrelated to transfusion
  • Female patients with reproductive potential must have a negative serum pregnancy test at screening. Patients must have signed an informed consent

You may not qualify if:

  • Uncontrolled hypertension
  • History (within 6 months) of uncontrolled cardiac arrhythmias, or history of pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
  • Transfusion within 28 days prior to first dose
  • Planned myelosuppressive chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry.

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 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

June 1, 2004

Study Completion

July 1, 2005

Last Updated

June 10, 2011

Record last verified: 2010-03