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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

October 8, 2008

Last Updated Date

May 9, 2009

Start Date ^†

October 2007

Current Primary Outcome Measures ^†

Number of courses of G-CSF required [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00770172 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

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

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Supportive Care, Randomized, Open Label

Condition ^†

Chemotherapeutic Agent Toxicity
Neutropenia
Unspecified Adult Solid Tumor, Protocol Specific

Intervention ^†

Biological: filgrastim

Study Arms / Comparison Groups

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

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

140

Completion Date

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

France

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00770172

Responsible Party

Secondary IDs ^††

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

Study Sponsor ^†

Centre Regional Francois Baclesse

Collaborators ^††

Investigators ^†

Study Chair:

Florence Joly, MD, PhD

Centre Regional Francois Baclesse

Information Provided By

National Cancer Institute (NCI)

Verification Date

December 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.