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

May 12, 2011 updated by: Centre Francois Baclesse

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Caen, France, 14076
        • Centre Regional Francois Baclesse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: filgrastim
Given subcutaneously
Experimental: Arm II
Patients receive G-CSF SC every 2 days on days 10-20 for up to 6 injections.
Biological: filgrastim
Given subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Number of courses of G-CSF required

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse

Investigators

  • Study Chair: Florence Joly, MD, PhD, Centre Francois Baclesse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

October 8, 2008

First Submitted That Met QC Criteria

October 8, 2008

First Posted (Estimate)

October 9, 2008

Study Record Updates

Last Update Posted (Estimate)

May 13, 2011

Last Update Submitted That Met QC Criteria

May 12, 2011

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000599523
  • FRE-CFB-LENO-12
  • INCA-RECF0515
  • EUDRACT-2007-002742-38
  • CFB-2007-02
  • CHUGAI-FRE-CFB-LENO-12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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