PROCRIT (Epoetin Alfa) 60,000 Units Administered Once Every Two Weeks in Anemic Cancer Patients Who Are Not Receiving Chemotherapy or Radiation Therapy
A Pilot Study to Evaluate the Response Rate of PROCRIT� (Epoetin Alfa) at 60,000 Units Every Two Weeks in Anemic Cancer Patients Not Receiving Chemotherapy Or Radiation Therapy
1 other identifier
interventional
57
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of Epoetin alfa administered at 60,000 Units every two weeks in cancer patients who are not receiving chemotherapy or radiation therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Feb 2004
Shorter than P25 for phase_2
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
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 13, 2006
CompletedFirst Posted
Study publicly available on registry
October 16, 2006
CompletedMay 18, 2011
April 1, 2010
October 13, 2006
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint was to evaluate hematopoietic response, defined as >= 2 g/dL Hb increase from baseline and/or Hb >= 12 g/dL over the course of the study and independent of transfusion within 28 days.
Secondary Outcomes (1)
Secondary endpoints included the effects of PROCRIT (Epoetin alfa) on transfusion requirements, on Quality of Life as measured by the Linear Analog Scale Assessment (LASA) and FACT-An tools as well as time to hemoglobin response.
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have histologically confirmed diagnosis of non-myeloid malignancy
- Baseline hemoglobin value of \<= 11 g/dL unrelated to transfusion
- Patients must not be receiving or planning to receive chemotherapy or radiotherapy within the 16-week study period. However, patients receiving hormonal therapy or non-myelosuppressive therapies are allowable
- Female patients with reproductive potential must have a negative serum pregnancy test at screening.
You may not qualify if:
- Patients must not have uncontrolled hypertension or a history (within 6 months) of uncontrolled cardiac arrhythmias, pulmonary emboli, deep vein thrombosis, ischemic stroke, other arterial or venous thrombotic events (excluding superficial thromboses), or known history of chronic coagulation disorder
- No transfusion within 28 days prior to first dose
- No planned chemotherapy or radiation during study and no prior chemotherapy within 8 weeks or radiation within 4 weeks of study entry
- No prior treatment with Epoetin alfa or any other erythropoietic agent within the previous two months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
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
October 13, 2006
First Posted
October 16, 2006
Study Start
February 1, 2004
Study Completion
March 1, 2005
Last Updated
May 18, 2011
Record last verified: 2010-04