- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00388336
PROCRIT (Epoetin Alfa) 60,000 Units Administered Once Every Two Weeks in Anemic Cancer Patients Who Are Not Receiving Chemotherapy or Radiation Therapy
A Pilot Study to Evaluate the Response Rate of PROCRIT� (Epoetin Alfa) at 60,000 Units Every Two Weeks in Anemic Cancer Patients Not Receiving Chemotherapy Or Radiation Therapy
Study Overview
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 the effectiveness of PROCRIT (Epoetin alfa) on hematopoietic response (effect on red blood cells) when administered at 60,000 Units subcutaneously (under the skin) every two weeks in anemic patients with cancer who were not receiving chemotherapy or radiation therapy.
Treatment with study drug was for a maximum of 12 weeks followed by a 4-week observation period after the last dose of the study drug had been administered.
Safety and efficacy evaluations were performed at specified intervals throughout the study and included assessment of laboratory tests (Complete Blood Count [CBC], Serum Chemistry [including hemoglobin level]), vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events. All patients enrolled in this study received pharmacologic ferrous sulfate 325 mg by mouth once a day or an equivalent formulation, as tolerated, unless it was determined by the physician that the patient should not receive it. All patient's received injections of PROCRIT (Epoetin alfa) 60,000 Units under the skin once every two weeks. If after 4 weeks of treatment, the patient's hemoglobin level did not increase by >= 1 g/dL, the Epoetin alfa dose was increased to 80,000 Units every 2 weeks. Study drug was administered for a maximum of 12 weeks followed by a 4-week observation period after the last dose of study drug. Epoetin alfa doses were reduced or held as needed depending on the patients' hemoglobin level.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary endpoint was to evaluate hematopoietic response, defined as >= 2 g/dL Hb increase from baseline and/or Hb >= 12 g/dL over the course of the study and independent of transfusion within 28 days.
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Secondary Outcome Measures
Outcome Measure |
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Secondary endpoints included the effects of PROCRIT (Epoetin alfa) on transfusion requirements, on Quality of Life as measured by the Linear Analog Scale Assessment (LASA) and FACT-An tools as well as time to hemoglobin response.
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Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR004594
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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