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

Sponsored by:	Centre Regional Francois Baclesse
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00770172

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
Cancer-Related Problem/Condition Unspecified Adult Solid Tumor, Protocol Specific	Drug: filgrastim	Phase III

MedlinePlus related topics: Cancer

Drug Information available for: Filgrastim Sargramostim Granulocyte-macrophage colony-stimulating factor Granulocyte colony-stimulating factor Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label
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

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
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental 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.	Drug: filgrastim Given subcutaneously
Arm II: Experimental Patients receive G-CSF SC every 2 days on days 10-20 for up to 6 injections.	Drug: 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

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

Locations

France
Centre Regional Francois Baclesse	Recruiting
Caen, France, 14076
Contact: Florence Joly, MD, PhD 33-02-31-45-50-17 f.joly@baclesse.fr

Sponsors and Collaborators

Centre Regional Francois Baclesse

Investigators

Study Chair:

Florence Joly, MD, PhD

Centre Regional Francois Baclesse

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00770172
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

chemotherapeutic agent toxicity
neutropenia
unspecified adult solid tumor, protocol specific
neutropenia

Study placed in the following topic categories:

Neutropenia
Hematologic Diseases
Benzocaine
Agranulocytosis

Leukocyte Disorders
Leukopenia
Granulocytopenia

ClinicalTrials.gov processed this record on January 16, 2009