Phase III Placebo-Controlled, Randomized, Double-Blind Comparison Of Etanercept (Enbrel) Versus Placebo For The Treatment Of Cancer-Associated Weight Loss And Anorexia
- 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
- 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
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.
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Comparison of weight gain and rate of weight change
Aminah Jatoi, MD
United States: Federal Government
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|MBCCOP - Hawaii||Honolulu, Hawaii 96813|
|CCOP - Upstate Carolina||Spartanburg, South Carolina 29303|
|CCOP - Wichita||Wichita, Kansas 67214-3882|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Illinois Oncology Research Association||Peoria, Illinois 61602|
|CCOP - Carle Cancer Center||Urbana, Illinois 61801|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|CCOP - Michigan Cancer Research Consortium||Ann Arbor, Michigan 48106|
|CCOP - Cedar Rapids Oncology Project||Cedar Rapids, Iowa 52403-1206|
|Rapid City Regional Hospital||Rapid City, South Dakota 57709|
|CCOP - Sioux Community Cancer Consortium||Sioux Falls, South Dakota 57105-1080|
|CCOP - Geisinger Clinic and Medical Center||Danville, Pennsylvania 17822-2001|
|MBCCOP - Gulf Coast||Mobile, Alabama 36688|
|CCOP - Oklahoma||Tulsa, Oklahoma 74136|
|Cancer Care Center at Medcenter One Hospital||Bismarck, North Dakota 58501|
|Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center||Sioux City, Iowa 51101|