Docetaxel and Gemcitabine With Filgrastim-SD/01 Support in Patients With Advanced Non-Small Cell Lung Carcinoma
Docetaxel and Gemcitabine given on day 1 and 8 of a 21-day schedule has substantial activity
in non-small cell lung cancer. Both first and second-line patients have response rates
comparable to or better than other standard combination regimens. Grade 3/4 neutropenia
occurs in up to half of patients not given growth factor support.
Studies demonstrate that a single dose of Filgrastim-SF/01 at 100 mg/kg effectively enhances
post chemotherapy neutrophil recovery in a manner similar to that of daily Filgrastim. This
current study is designed to characterize the incidence of grade 3/4 neutropenia when a
fixed dose of Filgrastim-SD/01 is added to a well-studied myelosuppressive chemotherapy
regimen consisting of Gemcitabine and Docetaxel.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Lee S Schwartzberg, MD, FACP
The West Clinic, PC
United States: Food and Drug Administration
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