G-CSF in Preventing Neutropenia in Patients With Solid Tumors Who Are 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.
|Chemotherapeutic Agent Toxicity Neutropenia Unspecified Adult Solid Tumor, Protocol Specific||Biological: filgrastim||Phase 3|
|Study Design:||Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Supportive Care
|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|
- Number of courses of G-CSF required
|Study Start Date:||October 2007|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: 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.
Experimental: Arm II
Patients receive G-CSF SC every 2 days on days 10-20 for up to 6 injections.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00770172
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Study Chair:||Florence Joly, MD, PhD||Centre Francois Baclesse|