Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-02 @ 5:17 AM
Study NCT ID:
NCT00046904
Status:
COMPLETED
Last Update Posted:
2011-05-05
First Post:
2002-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer
Sponsor:
Mayo Clinic
Organization:
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 4.6 kg vs at least 4.6 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 4.6 kg vs at least 4.6 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:
True
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?: