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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00770172
First received: October 8, 2008
Last updated: May 12, 2011
Last verified: December 2008
  Purpose

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.


Condition Intervention Phase
Chemotherapeutic Agent Toxicity
Neutropenia
Unspecified Adult Solid Tumor, Protocol Specific
Biological: filgrastim
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Number of courses of G-CSF required [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: October 2007
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770172

Locations
France
Centre Regional Francois Baclesse
Caen, France, 14076
Sponsors and Collaborators
Centre Francois Baclesse
Investigators
Study Chair: Florence Joly, MD, PhD Centre Francois Baclesse
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00770172     History of Changes
Other Study ID Numbers: CDR0000599523, FRE-CFB-LENO-12, INCA-RECF0515, EUDRACT-2007-002742-38, CFB-2007-02, CHUGAI-FRE-CFB-LENO-12
Study First Received: October 8, 2008
Last Updated: May 12, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
chemotherapeutic agent toxicity
neutropenia
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasms
Neutropenia
Agranulocytosis
Hematologic Diseases
Leukocyte Disorders
Leukopenia
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 19, 2014