FIRST - Study of Pegfilgrastim Administered in the First and Subsequent Cycles of Myelosuppressive Chemotherapy

Neutropenia Clinical Trial

Official title:

A Multicenter, Open-label, Phase 4 Study of Pegfilgrastim Administered in the First and Subsequent Cycles of Myelosuppressive Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00125723
• Other study ID #: 20030218
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2005
• Last updated: December 22, 2010
• Start date: May 2004
• Est. completion date: December 2005

Study information

• Verified date: December 2010
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to assess the impact of first and subsequent cycle pegfilgrastim on neutropenia events (such as hospitalizations, dose reductions and delays) in patients receiving myelosuppressive chemotherapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2252
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: - Pathologically confirmed diagnosis of the following malignancies:

breast, non-Hodgkin's lymphoma (NHL), Hodgkin's disease, ovarian, colorectal, lung or other - Planned administration of a new myelosuppressive every 14 (q14), q21, or q28 day chemotherapy - Written informed consent for participation in the study before any study-specific procedures are performed, including screening and registration Exclusion Criteria: - Planned concomitant therapeutic radiation - Diagnosis of acute or chronic leukemia or myelodysplastic syndrome - Prior stem-cell transplantation (includes bone-marrow transplantation) - Medical diagnosis of chronic neutropenia of any cause not related to cancer - Current cytotoxic, biologic, or immunologic therapy for unrelated conditions - Subject has active infection requiring treatment - Known HIV-positive subjects - Subject of child-bearing potential is evidently pregnant (e.g., positive HCG test) or is breast feeding - Subject of child-bearing potential is not using adequate contraceptive precautions - Known sensitivity to E. coli derived drug products (e.g., filgrastim, HUMULIN® insulin, L-asparaginase, HUMATROPE® growth hormone, INTRON A®) - Any psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with study protocol procedures - Subject is currently enrolled in, or has not yet completed at least 30 days since ending another device or drug trial(s) or is receiving, or plans to receive, other investigational agent(s) not approved by the Food and Drug Administration (FDA)

Study Design

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

Related Conditions & MeSH terms

• Neutropenia

Intervention

Other:
• PI Discretion
PI Discretion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

References & Publications (2)

Noga SJ, Choksi JK, Ding B, Dreiling L, Ozer H. Low incidence of neutropenic events in patients with lymphoma receiving first-cycle pegfilgrastim with chemotherapy: results from a prospective community-based study. Clin Lymphoma Myeloma. 2007 May;7(6):413 — View Citation

Ozer H, Mirtsching B, Rader M, Luedke S, Noga SJ, Ding B, Dreiling L. Neutropenic events in community practices reduced by first and subsequent cycle pegfilgrastim use. Oncologist. 2007 Apr;12(4):484-94. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	dose delays and dose reductions and neutropenic events		during treatment	No

External Links

•   AmgenTrials clinical trials website