RAPID-2. A Study to Evaluate the Effectiveness of Alternate Dosing of PROCRIT (Epoetin Alfa) in Maintaining Hemoglobin Levels in Patients With Chemotherapy Related Anemia
Information source: Ortho Biotech, Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chemotherapy; Cancer; Anemia
Intervention: epoetin alfa (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: Ortho Biotech Products, L.P. Official(s) and/or principal investigator(s):
Ortho Biotech Products, L.P. Clinical Trial, Study Director, Affiliation: Ortho Biotech, Inc.
Summary
The purpose of this study was to determine if alternate dosing of Epoetin alfa was effective
in maintaining hemoglobin levels in patients with chemotherapy related anemia.
Clinical Details
Official title: Retrospective Review of Alternate PROCRIT Dosing In Patients With Chemotherapy Related Anemia
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: Frequency and percentage of subjects in each dosing regimen will be summarized. Hemoglobin (Hb) response and maintenance of initial treatment phase Hb with alternate doses of Epoetin alfa. Time and reasons for discontinuing Epoetin alfa.
Detailed description:
This was a retrospective chart review of patients with chemotherapy related anemia. Two
hundred (200) patients with chemotherapy related anemia were to have received PROCRIT
(Epoetin alfa) on a weekly schedule (e. g., once every week or more frequently) for at least 4
weeks, followed by a maintenance PROCRIT (Epoetin alfa) schedule of less frequent dosing
(e. g. once every 2 weeks, once every 3 weeks, or once every 4 weeks) for at least 6 weeks.
Hemoglobin response and maintenance of initial treatment phase hemoglobin with alternate
doses of PROCRIT (Epoetin alfa) were to be evaluated. Study sites were to record data in a
Case Report Form which would then be entered into a database. Data was to be recorded,
starting with the PROCRIT (Epoetin alfa) initiation phase (at least 4 weeks duration), and
extending through at least 6 weeks of maintenance therapy. A minimum of 20 study sites were
to be enrolled in the data collection process. Data obtained was to be analyzed to reflect
alternate dosing patterns of PROCRIT (Epoetin alfa) therapy. The frequency and percentage of
patients receiving each dosing regimen were to be summarized. Hemoglobin response and
maintenance of initial treatment phase hemoglobin with alternate doses of PROCRIT (Epoetin
alfa) were to be evaluated. If PROCRIT (Epoetin alfa) was discontinued, the time and
reason(s) for discontinuation were to be recorded.
Patients were to have received PROCRIT (Epoetin alfa) subcutaneous injection on a weekly
schedule (e. g., once every week or more frequently) for at least 4 weeks, followed by a
maintenance PROCRIT (Epoetin alfa) schedule of less frequent dosing (e. g. once every 2 weeks,
3 weeks, or 4 weeks) for at least 6 weeks.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with chemotherapy related anemia
- Patients with a diagnosis of malignancy
- Patients with initial weekly PROCRIT (Epoetin alfa) therapy for at least 4 weeks
- Patients must have received PROCRIT (Epoetin alfa) maintenance therapy with less
frequent dosing (e. g. every 2 weeks, every 3 weeks, every 4 weeks) for at least 6
weeks immediately following once weekly dosing.
Exclusion Criteria:
- No previous diagnosis of hemolytic anemia or myelodysplasia
Locations and Contacts
Additional Information
For FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ Additional information is provided at the following link:http://dailymed.nlm.nih.gov/dailymed/about.cfm For FDA Safety Alerts and Recalls refer to the following link:www.fda.gov/MEDWATCH/safety.htm
Starting date: November 2002
Ending date: March 2003
Last updated: July 2, 2007
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