A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib in Patients With Advanced Cancer
- Compare the symptom burden and functional status, as measured by the physical
well-being subscale of the Functional Assessment of Cancer Therapy-General (FACT-G), of
patients with advanced cancer treated with celecoxib vs placebo.
- Compare pain, as measured by the Brief Pain Inventory, in patients treated with these
- Compare the need for opioid analgesics, as measured by the oral morphine equivalent of
analgesics used, in patients treated with these drugs.
- Compare weight loss in patients treated with these drugs.
- Compare quality of life, as measured by the FACT-G, in patients treated with these
- Compare the median survival of patients treated with these drugs.
- Determine the toxicity of celecoxib in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to ECOG performance status (0 or 1 vs 2 or 3), need for opioid
analgesics within the past 2 weeks (yes vs no), and weight loss as percentage of baseline
body weight (< 5% vs ≥ 5%). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral celecoxib twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues in
the absence of unacceptable toxicity.
Quality of life is assessed at baseline and at 2, 6, and 12 weeks.
Patients are followed every 3 months for 2 years and then every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 296 patients (148 per treatment arm) will be accrued for this
study within 2 years.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Donald P. Lawrence, MD
Tufts Medical Center