Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
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
RATIONALE: Colony-stimulating factors, such as G-CSF, may increase the number of white blood
cells found in bone marrow or peripheral blood and may prevent persistent neutropenia in
patients receiving chemotherapy. It is not yet known which regimen of G-CSF may be more
effective in preventing neutropenia.
PURPOSE: This randomized phase III trial is comparing two different regimens of G-CSF to see
how well it works in preventing persistent neutropenia in patients with solid tumors who are
receiving chemotherapy.
OBJECTIVES:
Primary
- Determine the efficacy of filgrastim (G-CSF) in preventing persistent moderate
neutropenia in patients with solid tumors while maintaining chemotherapy courses.
Secondary
- 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
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