A Randomized, Prospective Double-Blind, Placebo-Controlled Trial of Prophylactic Oral Levofloxacin Following Chemotherapy for Lymphoma and Solid Tumors
- Determine whether prophylactic treatment with levofloxacin reduces the rate of clinical
infection in patients receiving myelosuppressive antineoplastic chemotherapy for solid
tumors or lymphoma.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified
according to age (under 40 vs 40-59 vs 60 and over), type of cancer (non-Hodgkin's lymphoma
vs Hodgkin's lymphoma vs breast vs germ cell vs small cell lung cancer vs other), and
participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral levofloxacin once daily for 7 consecutive days during the
expected neutrophil nadir of each chemotherapy course.
- Arm II: Patients receive an oral placebo once daily for 7 consecutive days as in arm I.
Treatment in both arms continues for up to 6 courses in the absence of unacceptable side
effects or allergy or a clear continuing indication for the prophylactic use of
antibacterial agents during subsequent courses.
PROJECTED ACCRUAL: A total of 1,500 patients (750 per arm) will be accrued for this study
within 3 years.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Steven M. Neil, MB, MA, BS, PhD, DTMH, MRCP
University Hospital Birmingham
United States: Federal Government