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

NCT00770172 | Completed Phase 3

• 6 other identifiers: CDR0000599523FRE-CFB-LENO-12INCA-RECF0515EUDRACT-2007-002742-38CFB-2007-02CHUGAI-FRE-CFB-LENO-12
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of courses of G-CSF required

Study Arms (2)

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.

Biological: filgrastim

Arm II

EXPERIMENTAL

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

Biological: filgrastim

Interventions

filgrastim BIOLOGICAL

Given subcutaneously

Arm I; Arm II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (1)

Centre Regional Francois Baclesse

Caen, 14076, France

Location

MeSH Terms

Conditions

Neutropenia

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Florence Joly, MD, PhD

  Centre Francois Baclesse

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: October 1, 2007
• Primary Completion: May 1, 2011
• Last Updated: May 13, 2011

Record last verified: 2008-12

Locations

FR (1)