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
18 Years
N/A
Both
Anemia, Neoplasms
Trial Information
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
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 of PROCRIT (Epoetin alfa) with regard to hematopoietic response
when administered at 40,000 Units subcutaneously (under the skin) once per week in anemic
patients with cancer not receiving chemotherapy or radiation therapy. Hematological
laboratory tests (hemoglobin and hematocrit), vital signs (blood pressure) and occurrence
and severity of adverse events will be assessed throughout the study. Patients will receive
a PROCRIT (Epoetin alfa) injection (40,000 Units per injection) under the skin once every
week for a maximum of 13 weeks. Doses may be reduced depending on the patients' hemoglobin
level.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Principal Investigator
Ortho Biotech Products, L.P. Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Ortho Biotech Products, L.P.
Authority:
United States: Institutional Review Board
Study ID:
CR005113
NCT ID:
NCT00350090
Start Date:
September 2002
Completion Date:
March 2004
Related Keywords:
- Anemia
- Neoplasms
- Anemia
- Neoplasms
- Hemoglobin values
- Anemia
- Neoplasms
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