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

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)