G-CSF in Preventing Neutropenia in Patients With Solid Tumors Who Are Receiving Chemotherapy

Phase 3

Completed

• Conditions: Chemotherapeutic Agent Toxicity; Neutropenia; Unspecified Adult Solid Tumor, Protocol Specific
• Interventions: Biological: filgrastim

• Registration Number: NCT00770172
• Lead Sponsor: Centre Francois Baclesse

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.

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-10-08
• Study First Submitted QC: 2008-10-08
• Study First Posted: 2008-10-09
• Status Verified: 2008-12
• Primary Completion: 2011-05
• Last Update Submitted: 2011-05-12
• Last Update Posted: 2011-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm I	filgrastim	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	filgrastim	Patients receive G-CSF SC every 2 days on days 10-20 for up to 6 injections.

Primary Outcome Measures

Name	Time	Method
Number of courses of G-CSF required

Trial Locations

Locations (1)

Centre Regional Francois Baclesse; 🇫🇷 Caen, France