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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00770172
• Other study ID #: CDR0000599523
• Secondary ID: FRE-CFB-LENO-12I
• Status: Completed
• Phase: Phase 3
• First received: October 8, 2008
• Last updated: May 12, 2011
• Start date: October 2007

Study information

• Verified date: December 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of solid tumor

• Receiving chemotherapy in any line of treatment (adjuvant or metastatic)

• Chemotherapy courses repeating every 21 days or beginning on day 8 allowed

• Received at least 2 prior courses of chemotherapy

• Moderate neutropenia (grade 1-3) leading to a delay of the first course by = 7 days or a delay of the second course of treatment

PATIENT CHARACTERISTICS:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No known hypersensitivity to filgrastim (G-CSF) or any of its components

• No severe immunodepression

• No malignant hematological disease

• No history of psychiatric illness

• No patients deprived of liberty or under guardianship

• No psychological, familial, social, or geographical reasons preventing follow-up

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chemotherapeutic Agent Toxicity
• Neutropenia
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Biological:
• filgrastim
Given subcutaneously

Locations

Country	Name	City	State
France	Centre Regional Francois Baclesse	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of courses of G-CSF required			No