Moderate Persistent Neutropenia: Comparison of Administration of G-CSF (Granulocyte Colony Stimulating Factor) 1 Day Out of 2 Versus Traditional Schedules to Maintain Dose Intensity. Phase III Multicenter Study in Patients With Solid Tumors Receiving Chemotherapy
- Determine the efficacy of filgrastim (G-CSF) in preventing persistent moderate
neutropenia in patients with solid tumors while maintaining chemotherapy courses.
- Compare the tolerability of 2 regimens of G-CSF in these patients.
- Determine the number of courses of G-CSF needed in each regimen.
- Evaluate the frequency of infections.
- Determine dose intensity.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily for 6 days
beginning 1 week after the start of chemotherapy (days 7-12). If chemotherapy begins on
day 8, patients receive G-CSF SC on days 9-14.
- Arm II: Patients receive G-CSF SC every 2 days on days 10-20 for up to 6 injections.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Number of courses of G-CSF required
Florence Joly, MD, PhD
Centre Francois Baclesse
United States: Federal Government