A Randomized, Double Blind, Placebo-Controlled Trial of Celecoxib in Patients With Advanced Cancer

OBJECTIVES:

Primary

• 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.

Secondary

• Compare pain, as measured by the Brief Pain Inventory, in patients treated with these drugs.
• 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 drugs.
• Compare the median survival of patients treated with these drugs.
• Determine the toxicity of celecoxib in these patients.