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

Cancer Clinical Trial

Official title:

Retrospective Review of Alternate PROCRIT Dosing In Patients With Chemotherapy Related Anemia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00495378
• Other study ID #: CR005128
• Status: Terminated
• Phase: Phase 4
• First received: June 29, 2007
• Last updated: December 19, 2016
• Start date: November 2002
• Est. completion date: March 2003

Study information

• Verified date: June 2007
• Source: Ortho Biotech Products, L.P.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Cancer
• Chemotherapy

Intervention

Drug:
• epoetin alfa

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ortho Biotech Products, L.P.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   Additional information is provided at the following link:http://dailymed.nlm.nih.gov/dailymed/about.cfm
•   For FDA Approved Product labeling, refer to the following link:http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
•   For FDA Safety Alerts and Recalls refer to the following link:www.fda.gov/MEDWATCH/safety.htm