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

Primary Purpose

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

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
filgrastim
Sponsored by
Centre Francois Baclesse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapeutic Agent Toxicity focused on measuring chemotherapeutic agent toxicity, neutropenia, unspecified adult solid tumor, protocol specific

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Regional Francois Baclesse

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

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.

Patients receive G-CSF SC every 2 days on days 10-20 for up to 6 injections.

Outcomes

Primary Outcome Measures

Number of courses of G-CSF required

Secondary Outcome Measures

Full Information

First Posted
October 8, 2008
Last Updated
May 12, 2011
Sponsor
Centre Francois Baclesse
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1. Study Identification

Unique Protocol Identification Number
NCT00770172
Brief Title
G-CSF in Preventing Neutropenia in Patients With Solid Tumors Who Are Receiving Chemotherapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centre Francois Baclesse

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapeutic Agent Toxicity, Neutropenia, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
chemotherapeutic agent toxicity, neutropenia, unspecified adult solid tumor, protocol specific

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
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 Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive G-CSF SC every 2 days on days 10-20 for up to 6 injections.
Intervention Type
Biological
Intervention Name(s)
filgrastim
Intervention Description
Given subcutaneously
Primary Outcome Measure Information:
Title
Number of courses of G-CSF required

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence Joly, MD, PhD
Organizational Affiliation
Centre Francois Baclesse
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Regional Francois Baclesse
City
Caen
ZIP/Postal Code
14076
Country
France

12. IPD Sharing Statement

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

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