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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00495378

Enrollment

Registered

2007-07-03

Start date

2002-11-30

Completion date

2003-03-31

Last updated

2016-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Cancer, Chemotherapy

Keywords

PROCRIT, Epoetin alfa, chemotherapy related anemia

Brief 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.

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.

Interventions

DRUGepoetin alfa

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026