Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer
- Conditions
- CachexiaUnspecified Adult Solid Tumor, Protocol SpecificAnorexia
- Registration Number
- NCT00046904
- Lead Sponsor
- Mayo Clinic
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- 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 Comparison of weight gain and rate of weight change
- Secondary Outcome Measures
Name Time Method Differences in appetite Overall survival Incidence of treatment-related toxicity Comparison of quality of life (QOL) as assessed by the QOL UNISCALE and the Functional Assessment of Cancer Therapy-Anorexia/cachexia (FACT-An) scale at baseline, weekly for one month, and then monthly during study treatment
Trial Locations
- Locations (19)
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
๐บ๐ธSioux City, Iowa, United States
CCOP - Upstate Carolina
๐บ๐ธSpartanburg, South Carolina, United States
Mayo Clinic Scottsdale
๐บ๐ธScottsdale, Arizona, United States
CCOP - Carle Cancer Center
๐บ๐ธUrbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
๐บ๐ธCedar Rapids, Iowa, United States
CCOP - Oklahoma
๐บ๐ธTulsa, Oklahoma, United States
MBCCOP - Gulf Coast
๐บ๐ธMobile, Alabama, United States
Mayo Clinic Cancer Center
๐บ๐ธRochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
๐บ๐ธOmaha, Nebraska, United States
CCOP - Illinois Oncology Research Association
๐บ๐ธPeoria, Illinois, United States
Mayo Clinic - Jacksonville
๐บ๐ธJacksonville, Florida, United States
CCOP - Wichita
๐บ๐ธWichita, Kansas, United States
Cancer Care Center at Medcenter One Hospital
๐บ๐ธBismarck, North Dakota, United States
MBCCOP - Hawaii
๐บ๐ธHonolulu, Hawaii, United States
CCOP - Iowa Oncology Research Association
๐บ๐ธDes Moines, Iowa, United States
CCOP - Michigan Cancer Research Consortium
๐บ๐ธAnn Arbor, Michigan, United States
Rapid City Regional Hospital
๐บ๐ธRapid City, South Dakota, United States
CCOP - Geisinger Clinic and Medical Center
๐บ๐ธDanville, Pennsylvania, United States
CCOP - Sioux Community Cancer Consortium
๐บ๐ธSioux Falls, South Dakota, United States