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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00770172

Enrollment

140

Registered

2008-10-09

Start date

2007-10-31

Completion date

Unknown

Last updated

2011-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

BIOLOGICALfilgrastim

Given subcutaneously

Study design

Allocation

RANDOMIZED

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Number of courses of G-CSF required	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026