Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on August 03, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Anorexia; Cachexia; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: etanercept (Drug); anticachectic therapy (Procedure); complications of therapy assessment/management (Procedure); nutritional support (Procedure); supportive care/therapy (Procedure)
Phase: Phase 3
Status: No longer recruiting
Sponsored by: North Central Cancer Treatment Group
Official(s) and/or principal investigator(s):
Aminah Jatoi, MD, Study Chair, Affiliation: Mayo Clinic
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.
Phase III Placebo-Controlled, Randomized, Double-Blind Comparison Of Etanercept (Enbrel) Versus Placebo For The Treatment Of Cancer-Associated Weight Loss And Anorexia
Study design: Interventional, Supportive Care, Randomized, Double-Blind, Placebo Control
Primary outcome: Comparison of weight gain and rate of weight change
Differences in appetite
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
* 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.
Minimum age: 18 Years.
* Histologically or cytologically confirmed malignancy except brain cancer
- If the patient has multiple primaries or an unknown primary, the currently active cancer cannot be brain cancer
* Disease considered incurable with available therapies
* No clinical evidence of ascites
* Weight loss of at least 5 pounds (2. 3 kg) within the past 2 months (excluding perioperative weight loss) and/or estimated caloric intake of less than 20 cal/kg daily
* Weight gain determined by physician to be beneficial
* Patient perceives weight loss as a problem
* 18 and over
* ECOG 0-2
* More than 3 months
* Not specified
* Not specified
* Not specified
* No poorly controlled congestive heart failure
* No poorly controlled hypertension
* No pacemaker, implanted defibrillator, stents, or metal suture material in the heart or great vessels (for patients participating in the BIA translational portion of the study)
* No known mechanical obstruction of the alimentary tract
* No malabsorption
* No intractable vomiting (more than 5 episodes/week)
* Not concurrently receiving tube feedings or parenteral nutrition
* Able to reliably administer subcutaneous medication twice weekly
* Alert and mentally competent
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
* More than 1 month since prior infliximab
* No concurrent live vaccination
* Concurrent chemotherapy allowed
* At least 1 month since prior adrenal steroids
* No concurrent adrenal steroids (inhalant, topical, or optical steroids allowed)
- Concurrent short-term dexamethasone for chemotherapy-induced emesis is allowed
* Concurrent radiotherapy allowed
* Not specified
* More than 1 month since prior etanercept
* No concurrent evaluation with another device that injects an electrical current into the body (for patients participating in the bioelectrical impendance analysis [BIA] translational portion of the study)
Locations and Contacts
MBCCOP - Gulf Coast, Mobile, Alabama 36607, United States
Mayo Clinic Scottsdale, Scottsdale, Arizona 85259, United States
Mayo Clinic - Jacksonville, Jacksonville, Florida 32224, United States
MBCCOP - Hawaii, Honolulu, Hawaii 96813, United States
CCOP - Carle Cancer Center, Urbana, Illinois 61801, United States
CCOP - Illinois Oncology Research Association, Peoria, Illinois 61615-7828, United States
CCOP - Cedar Rapids Oncology Project, Cedar Rapids, Iowa 52403-1206, United States
CCOP - Iowa Oncology Research Association, Des Moines, Iowa 50309-1854, United States
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center, Sioux City, Iowa 51101-1733, United States
CCOP - Wichita, Wichita, Kansas 67214-3882, United States
CCOP - Michigan Cancer Research Consortium, Ann Arbor, Michigan 48106, United States
Mayo Clinic Cancer Center, Rochester, Minnesota 55905, United States
CCOP - Missouri Valley Cancer Consortium, Omaha, Nebraska 68106, United States
Cancer Care Center at Medcenter One Hospital, Bismarck, North Dakota 58501-5505, United States
CCOP - Oklahoma, Tulsa, Oklahoma 74136, United States
CCOP - Geisinger Clinic and Medical Center, Danville, Pennsylvania 17822-2001, United States
CCOP - Upstate Carolina, Spartanburg, South Carolina 29303, United States
CCOP - Sioux Community Cancer Consortium, Sioux Falls, South Dakota 57104, United States
Rapid City Regional Hospital, Rapid City, South Dakota 57709, United States
Clinical trial summary from the National Cancer Institute's PDQ® database
Last updated: March 5, 2007