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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Chemotherapeutic Agent Toxicity
- Sponsor
- Centre Francois Baclesse
- Enrollment
- 140
- Locations
- 1
- Primary Endpoint
- Number of courses of G-CSF required
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of courses of G-CSF required