Spots Global Cancer Trial Database for Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
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Trial Identification
Brief Title: Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)
Official Title: Prevention of Pegfilgrastim-Induced Bone Pain (PIBP): A Phase III Double-Blind Placebo-Controlled Clinical Trial
Study ID: NCT00602420
Study Description
Brief Summary: RATIONALE: Naproxen may help prevent or lessen bone pain caused by pegfilgrastim. It is not yet known whether naproxen is more effective than a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy. PURPOSE: This randomized phase III trial is studying naproxen to see how well it works compared with a placebo in preventing bone pain caused by pegfilgrastim in patients with non-hematologic cancer undergoing chemotherapy.
Detailed Description: OBJECTIVES: Primary * 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. Secondary * 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 Clinical Community Oncology Program (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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
MBCCOP - Hawaii, Honolulu, Hawaii, United States
CCOP - Central Illinois, Decatur, Illinois, United States
CCOP - Evanston, Evanston, Illinois, United States
CCOP - Wichita, Wichita, Kansas, United States
CCOP - Grand Rapids, Grand Rapids, Michigan, United States
CCOP - Metro-Minnesota, St. Louis Park, Minnesota, United States
CCOP - Kansas City, Kansas City, Missouri, United States
CCOP - Hematology-Oncology Associates of Central New York, Syracuse, New York, United States
CCOP - Southeast Cancer Control Consortium, Goldsboro, North Carolina, United States
CCOP - Columbus, Columbus, Ohio, United States
CCOP - Dayton, Dayton, Ohio, United States
CCOP - Greenville, Greenville, South Carolina, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina, United States
CCOP - Virginia Mason Research Center, Seattle, Washington, United States
CCOP - Northwest, Tacoma, Washington, United States
CCOP - Marshfield Clinic Research Foundation, Marshfield, Wisconsin, United States
Contact Details
Name: Jeffrey J. Kirshner, MD
Affiliation: CCOP - Hematology-Oncology Associates of Central New York
Role: STUDY_CHAIR
Name: Gary R. Morrow, PhD, MS
Affiliation: University of Rochester
Role: STUDY_CHAIR
Name: Jeffrey K. Giguere, MD, FACP
Affiliation: CCOP - Greenville
Role: STUDY_CHAIR
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