An Efficacy and Safety Study for Epoetin Alfa (PROCRIT) in Cancer Patients Not Receiving Chemotherapy or Radiation
A Pilot Study to Evaluate the Response Rate of Epoetin Alfa (PROCRIT) at 80,000 Units Every Three Weeks in Anemic Patients With Cancer Not Receiving Chemotherapy or Radiation Therapy
1 other identifier
interventional
51
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of epoetin alfa (PROCRIT®) administered 80,000 Units every three weeks in cancer patients that 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 below P25 for phase_3
Started Feb 2005
Shorter than P25 for phase_3
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, 2005
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedJune 10, 2011
May 1, 2010
September 13, 2005
June 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent of patients that achieved a hematopoietic response, defined as a Hb increase >= 2 g/dL and/or Hb = 12 g/dL during the study independent of transfusion within 28 days
Secondary Outcomes (1)
Transfusion requirements, change in Quality of Life scores measured by LASA & FACT-An, mean time to hematopoietic response (defined in Primary Endpoint) & mean time to >= 1g/dL change in Hb from baseline. Incidence of adverse events for study duration
Interventions
Eligibility Criteria
You may qualify if:
- 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 13-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
- 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 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 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
February 1, 2005
Study Completion
December 1, 2005
Last Updated
June 10, 2011
Record last verified: 2010-05