Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00046904
Status:
COMPLETED
Last Update Posted:
2011-05-05
First Post:
2002-10-03
Brief Title:
Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Phase III Placebo-Controlled Randomized Double-Blind Comparison Of Etanercept Enbrel Versus Placebo For The Treatment Of Cancer-Associated Weight Loss And Anorexia
Status:
COMPLETED
Status Verified Date:
2011-05
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 Etanercept is a substance that is being studied as a treatment for cachexia weight loss and anorexia lack of appetite in patients who have cancer It is not yet known whether etanercept is effective in improving cancer-related cachexia and anorexia
PURPOSE Randomized phase III trial to determine the effectiveness of etanercept in treating cancer-related cachexia and anorexia in patients who have advanced cancer
PURPOSE Randomized phase III trial to determine the effectiveness of etanercept in treating cancer-related cachexia and anorexia in patients who have advanced cancer
Detailed Description:
OBJECTIVES
Compare etanercept vs placebo in the treatment of cancer-related cachexia and anorexia in terms of weight measurement and rate of weight change in patients with advanced malignancies
Determine the effect of this drug on nausea and vomiting in these patients
Assess the functional status and appetite of patients treated with this drug
Assess the quality of life of patients treated with this drug
Determine the toxic effects of this drug in these patients
Determine whether this drug prolongs survival of these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to primary malignant disease lung vs gastrointestinal vs other severity of weight loss less than 46 kg vs at least 46 kg planned concurrent chemotherapy yes vs no age less than 50 vs 50 and over gender planned use of megestrol or other progestational agent yes vs no and GBU Prognostic Index good vs bad vs unsure Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive etanercept subcutaneously SC twice weekly
Arm II Patients receive placebo SC twice weekly Treatment in both arms continues for a maximum of 24 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline weekly for 1 month and then monthly during treatment
Patients are followed every 6 months for 5 years
PROJECTED ACCRUAL A total of 274 patients 137 per treatment arm will be accrued for this study within 19 months
Compare etanercept vs placebo in the treatment of cancer-related cachexia and anorexia in terms of weight measurement and rate of weight change in patients with advanced malignancies
Determine the effect of this drug on nausea and vomiting in these patients
Assess the functional status and appetite of patients treated with this drug
Assess the quality of life of patients treated with this drug
Determine the toxic effects of this drug in these patients
Determine whether this drug prolongs survival of these patients
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to primary malignant disease lung vs gastrointestinal vs other severity of weight loss less than 46 kg vs at least 46 kg planned concurrent chemotherapy yes vs no age less than 50 vs 50 and over gender planned use of megestrol or other progestational agent yes vs no and GBU Prognostic Index good vs bad vs unsure Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive etanercept subcutaneously SC twice weekly
Arm II Patients receive placebo SC twice weekly Treatment in both arms continues for a maximum of 24 weeks in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline weekly for 1 month and then monthly during treatment
Patients are followed every 6 months for 5 years
PROJECTED ACCRUAL A total of 274 patients 137 per treatment arm will be accrued for this study within 19 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCCTG-N00C1 | None | None | None |
| NCI-P02-0232 | None | None | None |
| MC00C8 | OTHER | None | None |
| 1497-00 | OTHER | Mayo Clinic IRB | None |