Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093678
Status:
WITHDRAWN
Last Update Posted:
2015-10-08
First Post:
2004-10-06
Brief Title:
Celecoxib in Managing Pain Weight Loss and Weakness in Patients With Advanced Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Randomized Double Blind Placebo-Controlled Trial of Celecoxib in Patients With Advanced Cancer
Status:
WITHDRAWN
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECOG-E1Z02 | None | None | None |