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

This study has been terminated.
(This study was stopped due to slow enrollment after enrolling 25 of 200 patients.)
Sponsor:
Information provided by:
Ortho Biotech, Inc.
ClinicalTrials.gov Identifier:
NCT00495378
First received: June 29, 2007
Last updated: July 2, 2007
Last verified: June 2007

June 29, 2007
July 2, 2007
November 2002
Not Provided
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.
Same as current
Complete list of historical versions of study NCT00495378 on ClinicalTrials.gov Archive Site
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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
Retrospective Review of Alternate PROCRIT Dosing In Patients With Chemotherapy Related Anemia

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chemotherapy
  • Cancer
  • Anemia
Drug: epoetin alfa
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
March 2003
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00495378
CR005128
No
Not Provided
Ortho Biotech Products, L.P.
Not Provided
Study Director: Ortho Biotech Products, L.P. Clinical Trial Ortho Biotech, Inc.
Ortho Biotech, Inc.
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP