Valdecoxib in Treating Chronic Pain in Cancer Patients

OBJECTIVES: I. Assess the analgesic efficacy of valdecoxib administered in addition to opioid medication in patients with chronic pain due to cancer or prior cancer therapy. II. Assess the safety of this drug in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to baseline average pain intensity score (2-4 vs 5-11). Patients are randomized to 1 of 2 treatment arms. Patients undergo a pretreatment period of 3-14 days to determine daily dose of sustained release and immediate release opioid medications required to adequately control pain with tolerable side effects. Arm I: Patients receive oral valdecoxib twice daily in addition to opioid medications. Arm II: Patients receive oral placebo twice daily in addition to opioid medications. Treatment continues for a maximum of 12 weeks in the absence of inadequate pain control or unacceptable toxicity. Patients record daily pain assessments and total daily opioid consumption. Patients also are contacted by telephone weekly for assessment of pain, opioid use, and adverse effects. PROJECTED ACCRUAL: A maximum of 260 patients will be accrued for this study.