An Open Label Randomized Study To Evaluate The Response Rate Of Epoetin Alfa (PROCRIT�) Versus No/Delayed PROCRIT Treatment In Patients With Cancer And Persistent Chemotherapy-Induced Myelosuppression (Anemia)
18 Years
N/A
Both
Anemia
Trial Information
An Open Label Randomized Study To Evaluate The Response Rate Of Epoetin Alfa (PROCRIT�) Versus No/Delayed PROCRIT Treatment In Patients With Cancer And Persistent Chemotherapy-Induced Myelosuppression (Anemia)
The purpose of this study is to evaluate hematologic response in patients receiving epoetin
alfa (PROCRIT®) therapy for persistent chemotherapy-induced myelosuppression (anemia) after
completion of chemotherapy administration as compared to patients who do not receive weekly
epoetin alfa (PROCRIT®) immediately after cessation of chemotherapy. Further, the duration
of treatment necessary to achieve these endpoints will be studied. A No/Delayed epoetin
alfa (PROCRIT®) treatment control (whereby patients in the control group will receive
epoetin alfa (PROCRIT®) if their Hb decreases to < 10g/dL during the study) will be used to
establish the frequency and magnitude of changes in clinical end points that may occur when
epoetin alfa (PROCRIT®) treatment is not continued (or started) for patients with residual
myelosuppression after chemotherapy administration has ended. A 2:1 randomization will be
used to give every patient a greater chance to receive immediate treatment (66.6% epoetin
alfa (PROCRIT®) treatment vs. 33.3% No/Delayed epoetin alfa (PROCRIT®) treatment). The
study will be powered to show differences between the two groups in hematologic response.
In this study, the hematologic response is defined as the proportion of patients who are
transfusion-free and are able to maintain their mean Hb level at >= 11 g/dL during the study
without a Hb drop to <= 10 g/dL and/or transfusion.
The study hypothesis was that immediate epoetin alfa (PROCRIT®) treatment would be more
effective in treatment of anemia than No/Delayed epoetin alfa (PROCRIT®) treatment in
patients with cancer and persistent chemotherapy-induced anemia. Patients will be
randomized 2:1 to receive epoetin alf or no epoetin treatment. The starting dose will be
40,000 Units weekly (QW) or the dose they were on prior to the study (30,000-60,000 Units
QW). If the Hb level decreases to <= 10 g/dL, PROCRIT will be initiated at a dose of 40,000
Units QW.
Inclusion Criteria:
- Histologically confirmed diagnosis of non-myeloid malignancy
- Baseline hemoglobin value >= 11 g/dL and <= 12 g/dL unrelated to transfusion
- Female patients with reproductive potential must have a negative serum pregnancy test
at screening. Patients must have signed an informed consent
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 myelosuppressive chemotherapy or radiation during study and no prior
chemotherapy within 8 weeks or radiation within 4 weeks of study entry.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
The primary efficacy endpoint is hematologic response, defined as follows: Transfusion free during study, and the average of post baseline Hb values > 11 g/dL without a post baseline Hb < 10 g/dL.
Principal Investigator
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Authority:
United States: Food and Drug Administration
Study ID:
CR004591
NCT ID:
NCT00210730
Start Date:
June 2004
Completion Date:
July 2005
Related Keywords:
- Anemia
- Anemia
- Neoplasm
- Hemoglobin Level
- Anemia
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