Status:
COMPLETED
PROCRIT (Epoetin Alfa) 60,000 Units Administered Once Every Two Weeks in Anemic Cancer Patients Who Are Not Receiving Chemotherapy or Radiation Therapy
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Ortho Biotech Clinical Affairs, L.L.C.
Conditions:
Anemia
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 th...
Detailed Description
This was an open-label (doctors and patients knew which drug was being administered), non-randomized (patients were assigned to treatment), multi-center pilot study with the objective to investigate t...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00388336
Start Date
February 1 2004
End Date
March 1 2005
Last Update
May 18 2011
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