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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000855', 'term': 'Anorexia'}, {'id': 'D002100', 'term': 'Cachexia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D013851', 'term': 'Thinness'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068800', 'term': 'Etanercept'}], 'ancestors': [{'id': 'D007141', 'term': 'Immunoglobulin Fc Fragments'}, {'id': 'D007128', 'term': 'Immunoglobulin Fragments'}, {'id': 'D010446', 'term': 'Peptide Fragments'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007127', 'term': 'Immunoglobulin Constant Regions'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D018124', 'term': 'Receptors, Tumor Necrosis Factor'}, {'id': 'D018121', 'term': 'Receptors, Cytokine'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'SUPPORTIVE_CARE'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'lastUpdateSubmitDate': '2011-05-04', 'studyFirstSubmitDate': '2002-10-03', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2011-05-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of weight gain and rate of weight change'}], 'secondaryOutcomes': [{'measure': 'Differences in appetite'}, {'measure': 'Overall survival'}, {'measure': 'Incidence of treatment-related toxicity'}, {'measure': '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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific', 'anorexia', 'cachexia'], 'conditions': ['Anorexia', 'Cachexia', 'Unspecified Adult Solid Tumor, Protocol Specific']}, 'referencesModule': {'references': [{'pmid': '17674351', 'type': 'RESULT', 'citation': '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.'}, {'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: Randomized phase III trial to determine the effectiveness of etanercept in treating cancer-related cachexia and anorexia in patients who have advanced cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* 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.\n* Determine the effect of this drug on nausea and vomiting in these patients.\n* Assess the functional status and appetite of patients treated with this drug.\n* Assess the quality of life of patients treated with this drug.\n* Determine the toxic effects of this drug in these patients.\n* Determine whether this drug prolongs survival of these patients.\n\nOUTLINE: 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.\n\n* Arm I: Patients receive etanercept subcutaneously (SC) twice weekly.\n* 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.\n\nQuality of life is assessed at baseline, weekly for 1 month, and then monthly during treatment.\n\nPatients are followed every 6 months for 5 years.\n\nPROJECTED ACCRUAL: A total of 274 patients (137 per treatment arm) will be accrued for this study within 19 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed malignancy except brain cancer\n\n * If the patient has multiple primaries or an unknown primary, the currently active cancer cannot be brain cancer\n* Disease considered incurable with available therapies\n* No clinical evidence of ascites\n* 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\n* Weight gain determined by physician to be beneficial\n* Patient perceives weight loss as a problem\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-2\n\nLife expectancy\n\n* More than 3 months\n\nHematopoietic\n\n* Not specified\n\nHepatic\n\n* Not specified\n\nRenal\n\n* Not specified\n\nCardiovascular\n\n* No poorly controlled congestive heart failure\n* No poorly controlled hypertension\n* 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)\n\nGastrointestinal\n\n* No known mechanical obstruction of the alimentary tract\n* No malabsorption\n* No intractable vomiting (more than 5 episodes/week)\n* Not concurrently receiving tube feedings or parenteral nutrition\n\nOther\n\n* Able to reliably administer subcutaneous medication twice weekly\n* Alert and mentally competent\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* More than 1 month since prior infliximab\n* No concurrent live vaccination\n\nChemotherapy\n\n* Concurrent chemotherapy allowed\n\nEndocrine therapy\n\n* At least 1 month since prior adrenal steroids\n* No concurrent adrenal steroids (inhalant, topical, or optical steroids allowed)\n\n * Concurrent short-term dexamethasone for chemotherapy-induced emesis is allowed\n\nRadiotherapy\n\n* Concurrent radiotherapy allowed\n\nSurgery\n\n* Not specified\n\nOther\n\n* More than 1 month since prior etanercept\n* 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)'}, 'identificationModule': {'nctId': 'NCT00046904', 'briefTitle': 'Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Phase III Placebo-Controlled, Randomized, Double-Blind Comparison Of Etanercept (Enbrel) Versus Placebo For The Treatment Of Cancer-Associated Weight Loss And Anorexia', 'orgStudyIdInfo': {'id': 'CDR0000257027'}, 'secondaryIdInfos': [{'id': 'NCCTG-N00C1'}, {'id': 'NCI-P02-0232'}, {'id': 'MC00C8', 'type': 'OTHER', 'domain': 'Mayo Clinic Cancer Center'}, {'id': '1497-00', 'type': 'OTHER', 'domain': 'Mayo Clinic IRB'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'etanercept', 'type': 'BIOLOGICAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '36607', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'MBCCOP - Gulf Coast', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic Scottsdale', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic - Jacksonville', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'MBCCOP - Hawaii', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '61615-7828', 'city': 'Peoria', 'state': 'Illinois', 'country': 'United States', 'facility': 'CCOP - Illinois Oncology Research Association', 'geoPoint': {'lat': 40.69365, 'lon': -89.58899}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'CCOP - Carle Cancer Center', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '52403-1206', 'city': 'Cedar Rapids', 'state': 'Iowa', 'country': 'United States', 'facility': 'CCOP - Cedar Rapids Oncology Project', 'geoPoint': {'lat': 42.00833, 'lon': -91.64407}}, {'zip': '50309-1854', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'CCOP - Iowa Oncology Research Association', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '51101-1733', 'city': 'Sioux City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center', 'geoPoint': {'lat': 42.49999, 'lon': -96.40031}}, {'zip': '67214-3882', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'CCOP - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '48106', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'CCOP - Michigan Cancer Research Consortium', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '68106', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'CCOP - Missouri Valley Cancer Consortium', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '58501-5505', 'city': 'Bismarck', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Cancer Care Center at Medcenter One Hospital', 'geoPoint': {'lat': 46.80833, 'lon': -100.78374}}, {'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'CCOP - Oklahoma', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '17822-2001', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CCOP - Geisinger Clinic and Medical Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'CCOP - Upstate Carolina', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '57709', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Rapid City Regional Hospital', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '57104', 'city': 'Sioux Falls', 'state': 'South Dakota', 'country': 'United States', 'facility': 'CCOP - Sioux Community Cancer Consortium', 'geoPoint': {'lat': 43.54369, 'lon': -96.72796}}], 'overallOfficials': [{'name': 'Aminah Jatoi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'oldNameTitle': 'Aminah Jatoi, M.D.', 'oldOrganization': 'Mayo Clinic Cancer Center'}}}}