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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neutropenia

Intervention / Treatment
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* Other: PI Discretion


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Intervention<br> | Other: PI Discretion<br>* PI Discretion<br>|
| Other: Intervention<br>PI Discretion | Other: PI Discretion<br>* PI Discretion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dose delays and dose reductions and neutropenic events |  | during treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phase 4 Clinical Trial, Chemotherapy, Neulasta®, Oncology, Malignancy