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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Biological: filgrastim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>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<br>* Given subcutaneously<br>|
| Experimental: Arm II<br>Patients receive G-CSF SC every 2 days on days 10-20 for up to 6 injections. | Biological: filgrastim<br>* Given subcutaneously<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of courses of G-CSF required |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chemotherapeutic agent toxicity, neutropenia, unspecified adult solid tumor, protocol specific