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
18 Years
N/A
Both
Chemotherapeutic Agent Toxicity, Neutropenia, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Number of courses of G-CSF required
Safety Issue:
No
Principal Investigator
Florence Joly, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Francois Baclesse
Authority:
United States: Federal Government
Study ID:
CDR0000599523
NCT ID:
NCT00770172
Start Date:
October 2007
Completion Date:
Related Keywords:
- Chemotherapeutic Agent Toxicity
- Neutropenia
- Unspecified Adult Solid Tumor, Protocol Specific
- chemotherapeutic agent toxicity
- neutropenia
- unspecified adult solid tumor, protocol specific
- Neutropenia
- Neoplasms
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