Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial
- To compare the efficacy of daily administration of naproxen vs placebo in preventing or
reducing the severity and duration of pegfilgrastim-induced bone pain (PIBP) in
patients with non-hematologic malignancies undergoing chemotherapy.
- To identify potential risk factors for the development of PIBP.
- To identify potential clinical predictors for the response or failure to respond to
naproxen in preventing PIBP.
- To assess the toxicity of naproxen when administered in the preventive setting.
OUTLINE: This is a multicenter study. Patients are stratified by CCOP site. Patients are
randomized to 1 treatment arm vs placebo.
- Arm I: Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is
administered (day 2, 3, or 4) and continuing for 5-8 days.
- Arm II: Patients receive matching placebo twice daily beginning on the day
pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Severity and duration of bone pain (day 1 being the day pegfilgrastim is administered) as measured by a daily diary
from baseline through day 5
Jeffrey J. Kirshner, MD
CCOP - Hematology-Oncology Associates of Central New York
United States: Federal Government
|MBCCOP - Hawaii||Honolulu, Hawaii 96813|
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Kansas City||Kansas City, Missouri 64131|
|CCOP - Southeast Cancer Control Consortium||Winston-Salem, North Carolina 27104-4241|
|CCOP - Metro-Minnesota||Saint Louis Park, Minnesota 55416|
|CCOP - Central Illinois||Springfield, Illinois 62526|
|CCOP - Columbus||Columbus, Ohio 43206|
|CCOP - Dayton||Kettering, Ohio 45429|
|CCOP - Greenville||Greenville, South Carolina 29615|
|CCOP - Evanston||Evanston, Illinois 60201|
|CCOP - Grand Rapids||Grand Rapids, Michigan 49503|
|CCOP - Virginia Mason Research Center||Seattle, Washington 98101|
|CCOP - Northwest||Tacoma, Washington 98405-0986|
|CCOP - Marshfield Clinic Research Foundation||Marshfield, Wisconsin 54449|
|CCOP - Hematology-Oncology Associates of Central New York||East Syracuse, New York 13057|