Status:
TERMINATED
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.
Lead Sponsor:
Ortho Biotech Products, L.P.
Conditions:
Anemia
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Detailed Description
This is an open-label (both the researcher and the patient in the study know the treatment that is being given), non-randomized, multi-center pilot study with the objective to investigate the efficacy...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2004
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT00350090
Start Date
September 1 2002
End Date
March 1 2004
Last Update
May 19 2011
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