Study Stopped
This study was stopped early due to slow enrollment.
A Study to Assess the Response Rate of PROCRIT (Epoetin Alfa) Given at a Dose of 40,000 Units Once a Week to Cancer Patients With Anemia Who Are Not Receiving Chemotherapy.
A Pilot Study to Evaluate the Response Rate of PROCRIT (Epoetin Alfa) at 40,000 Units Once Weekly in Anemic Cancer Patients Not Receiving Chemotherapy
1 other identifier
interventional
98
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the effectiveness and safety of PROCRIT (Epoetin alfa) administered at 40,000 Units weekly 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 P25-P50 for phase_3
Started Sep 2002
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
September 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 7, 2006
CompletedFirst Posted
Study publicly available on registry
July 10, 2006
CompletedMay 19, 2011
March 1, 2010
July 7, 2006
May 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hematologic response in terms of hemoglobin and transfusion requirements where hemoglobin response is characterized as minor > 1g/dL Hb increase or major > 2g/dL Hb increase.
Secondary Outcomes (1)
Secondary efficacy variables will include the effects of PROCRIT (Epoetin alfa) on transfusion requirements and on Quality of Life as measured by the Linear Analog Scale Assessment (LASA) tool.
Interventions
Eligibility Criteria
You may qualify if:
- Histologically confirmed diagnosis of non-myeloid malignancy
- Baseline hemoglobin value of less than or equal to 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:
- 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 Publications (1)
Shasha D, Williams D. Weekly epoetin alfa treatment of anemia in patients with cancer not undergoing therapy. J Support Oncol. 2006 Mar;4(3):129-35.
PMID: 16553139RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ortho Biotech Products, L.P. Clinical Trial
Ortho Biotech Products, L.P.
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
July 7, 2006
First Posted
July 10, 2006
Study Start
September 1, 2002
Study Completion
March 1, 2004
Last Updated
May 19, 2011
Record last verified: 2010-03