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

Centre Francois Baclesse

Status and phase: Completed; Phase 3

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

Treatments: Biological: filgrastim

Study type: Interventional

Funder types: Other

Identifiers

NCT00770172

INCA-RECF0515

FRE-CFB-LENO-12

EUDRACT-2007-002742-38

CFB-2007-02

CHUGAI-FRE-CFB-LENO-12

CDR0000599523

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

140 participants in 2 patient groups

Arm I

Experimental group

Description:

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.

Treatment:

Biological: filgrastim

Arm II

Experimental group

Description:

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

Treatment:

Biological: filgrastim