Status:
COMPLETED
G-CSF in Preventing Neutropenia in Patients With Solid Tumors Who Are Receiving Chemotherapy
Lead Sponsor:
Centre Francois Baclesse
Conditions:
Chemotherapeutic Agent Toxicity
Neutropenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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 * C...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00770172
Start Date
October 1 2007
Last Update
May 13 2011
Active Locations (1)
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1
Centre Regional Francois Baclesse
Caen, France, 14076