An Efficacy and Safety Study of PROCRIT (Epoetin Alfa) in Cancer Patients Receiving Chemotherapy Every Three Weeks
An Open-Labeled Pilot Study to Evaluate the Effects of High Dose PROCRIT (Epoetin Alfa) in Maintaining Hemoglobin Levels in Anemic Cancer Patients Receiving Chemotherapy on a Every Three Week Regimen
1 other identifier
interventional
115
0 countries
N/A
Brief Summary
The purpose of this study is to determine the effectiveness and safety of PROCRIT (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 80,000 Units once every three weeks (Q3W) to maintain a Hb range of 11.5 to 12.5 g/dL (Maintenance Phase) in cancer patients receiving chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 cancer
Started Mar 2003
Shorter than P25 for phase_2 cancer
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 Start
First participant enrolled
March 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
June 16, 2006
CompletedFirst Posted
Study publicly available on registry
June 20, 2006
CompletedJune 10, 2011
April 1, 2010
June 16, 2006
June 8, 2011
Conditions
Keywords
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
Eligibility Criteria
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 15 weeks to be administered every 3 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
- No 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 Publications (1)
Montoya VP, Xie J, Williams D, Woodman RC, Wilhelm FE. An extended maintenance dosing regimen of epoetin alfa 80,000 U every 3 weeks in anemic patients with cancer receiving chemotherapy. Support Care Cancer. 2007 Dec;15(12):1385-92. doi: 10.1007/s00520-007-0263-6. Epub 2007 May 31.
PMID: 17541653RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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
March 1, 2003
Study Completion
January 1, 2005
Last Updated
June 10, 2011
Record last verified: 2010-04