Celecoxib in Managing Pain, Weight Loss, and Weakness in Patients With Advanced Cancer
- Conditions
- Melanoma (Skin)Ovarian CancerSarcomaUnspecified Adult Solid Tumor, Protocol SpecificCachexiaLymphomaPain
- Registration Number
- NCT00093678
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method