Clinical Protocol for a Randomized Double-Blind, Placebo-Controlled Comparison of the Analgesic Activity of Valdecoxib (SC-65872) 40mg BID as Add-On Therapy to Opioid Medication in Patients With Chronic Cancer Pain
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.
Primary Purpose: Supportive Care
Susana Campos, MD, MPH
Dana-Farber Cancer Institute
United States: Federal Government
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Brigham and Women's Hospital||Boston, Massachusetts 02115|