Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer
NCT ID: NCT00046904
Last Updated: 2011-05-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
2003-05-31
Brief Summary
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PURPOSE: Randomized phase III trial to determine the effectiveness of etanercept in treating cancer-related cachexia and anorexia in patients who have advanced cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
DOUBLE
Interventions
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etanercept
Eligibility Criteria
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Inclusion Criteria
* 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
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* ECOG 0-2
Life expectancy
* More than 3 months
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Cardiovascular
* 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)
Gastrointestinal
* 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
Other
* 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:
Biologic therapy
* More than 1 month since prior infliximab
* No concurrent live vaccination
Chemotherapy
* Concurrent chemotherapy allowed
Endocrine therapy
* 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
Radiotherapy
* Concurrent radiotherapy allowed
Surgery
* Not specified
Other
* 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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Mayo Clinic
OTHER
Responsible Party
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Mayo Clinic Cancer Center
Principal Investigators
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Aminah Jatoi, MD
Role: STUDY_CHAIR
Mayo Clinic
Locations
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MBCCOP - Gulf Coast
Mobile, Alabama, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States
MBCCOP - Hawaii
Honolulu, Hawaii, United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
Sioux City, Iowa, United States
CCOP - Wichita
Wichita, Kansas, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States
Mayo Clinic Cancer Center
Rochester, Minnesota, United States
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States
Cancer Care Center at Medcenter One Hospital
Bismarck, North Dakota, United States
CCOP - Oklahoma
Tulsa, Oklahoma, United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States
Countries
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References
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Jatoi A, Dakhil SR, Nguyen PL, Sloan JA, Kugler JW, Rowland KM Jr, Soori GS, Wender DB, Fitch TR, Novotny PJ, Loprinzi CL. A placebo-controlled double blind trial of etanercept for the cancer anorexia/weight loss syndrome: results from N00C1 from the North Central Cancer Treatment Group. Cancer. 2007 Sep 15;110(6):1396-403. doi: 10.1002/cncr.22944.
Jatoi A, Dakhil SR, Kugler JW, et al.: A placebo-controlled trial of etanercept, a tumor necrosis factor (TNF) inhibitor, in patients with the cancer anorexia/weight loss syndrome. North Central Cancer Treatment Group (NCCTG) trial N00C1. [Abstract] J Clin Oncol 24 (Suppl 18): A-8534, 476s, 2006.
Other Identifiers
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NCCTG-N00C1
Identifier Type: -
Identifier Source: secondary_id
NCI-P02-0232
Identifier Type: -
Identifier Source: secondary_id
MC00C8
Identifier Type: OTHER
Identifier Source: secondary_id
1497-00
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000257027
Identifier Type: -
Identifier Source: org_study_id
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