NCT00093678

Celecoxib in Managing Pain, Weight Loss, and Weakness in Patients With Advanced Cancer

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Celecoxib may help relieve moderate or severe pain associated with cancer. It may also decrease weight loss and improve muscle strength in cancer patients. PURPOSE: This randomized clinical trial is studying celecoxib to see how well it works in managing pain, weight loss, and weakness in patients with advanced cancer.

Detailed description

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. 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.

Conditions

• Cachexia
• Lymphoma
• Melanoma (Skin)
• Ovarian Cancer
• Pain
• Sarcoma
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	celecoxib
PROCEDURE	anticachectic therapy
PROCEDURE	nutritional support
PROCEDURE	pain therapy
PROCEDURE	supportive care/therapy

Timeline

• First posted: 2004-10-08
• Last updated: 2015-10-08