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

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