Prevention of Pegfilgrastim-Induced Bone Pain (PIBP)

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.