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Clinical Trial Name - Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer
| Original Study ID : CDR0000257027 |
| Secondary ID : Array |
| NCT ID : NCT00046904 |
| Brief Title : Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer |
| Official Title : Phase III Placebo-Controlled, Randomized, Double-Blind Comparison Of Etanercept (Enbrel) Versus Placebo For The Treatment Of Cancer-Associated Weight Loss And Anorexia |
| 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. |
| Source : National Cancer Institute (NCI) |
| 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. |
| Overall Status : Completed |
| Start Date : May 2003 |
| Official Title : Phase 3 |
| Phase : Interventional |
| Study Design : Supportive Care, Randomized, Double-Blind, Placebo Control |
| Verification Date : October 2006 |
| First Received Date : October 3, 2002 |
| Trial Eligibility |
| Criteria : DISEASE CHARACTERISTICS: - 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) |
| Gender : Both |
| Minimum Age : 18 Years |
| Maximum Age : N/A |
| Healthy Volunteers : No |
| Facilities |
| Facility Name : MBCCOP - Gulf Coast |
| City : Mobile |
| State : Alabama |
| Zip Code : 36607 |
| Country : United States |
| Facility Name : Mayo Clinic Scottsdale |
| City : Scottsdale |
| State : Arizona |
| Zip Code : 85259 |
| Country : United States |
| Facility Name : Mayo Clinic - Jacksonville |
| City : Jacksonville |
| State : Florida |
| Zip Code : 32224 |
| Country : United States |
| Facility Name : MBCCOP - Hawaii |
| City : Honolulu |
| State : Hawaii |
| Zip Code : 96813 |
| Country : United States |
| Facility Name : CCOP - Carle Cancer Center |
| City : Urbana |
| State : Illinois |
| Zip Code : 61801 |
| Country : United States |
| Facility Name : CCOP - Illinois Oncology Research Association |
| City : Peoria |
| State : Illinois |
| Zip Code : 61615-7828 |
| Country : United States |
| Facility Name : CCOP - Cedar Rapids Oncology Project |
| City : Cedar Rapids |
| State : Iowa |
| Zip Code : 52403-1206 |
| Country : United States |
| Facility Name : CCOP - Iowa Oncology Research Association |
| City : Des Moines |
| State : Iowa |
| Zip Code : 50309-1854 |
| Country : United States |
| Facility Name : Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center |
| City : Sioux City |
| State : Iowa |
| Zip Code : 51101-1733 |
| Country : United States |
| Facility Name : CCOP - Wichita |
| City : Wichita |
| State : Kansas |
| Zip Code : 67214-3882 |
| Country : United States |
| Facility Name : CCOP - Michigan Cancer Research Consortium |
| City : Ann Arbor |
| State : Michigan |
| Zip Code : 48106 |
| Country : United States |
| Facility Name : Mayo Clinic Cancer Center |
| City : Rochester |
| State : Minnesota |
| Zip Code : 55905 |
| Country : United States |
| Facility Name : CCOP - Missouri Valley Cancer Consortium |
| City : Omaha |
| State : Nebraska |
| Zip Code : 68106 |
| Country : United States |
| Facility Name : Cancer Care Center at Medcenter One Hospital |
| City : Bismarck |
| State : North Dakota |
| Zip Code : 58501-5505 |
| Country : United States |
| Facility Name : CCOP - Oklahoma |
| City : Tulsa |
| State : Oklahoma |
| Zip Code : 74136 |
| Country : United States |
| Facility Name : CCOP - Geisinger Clinic and Medical Center |
| City : Danville |
| State : Pennsylvania |
| Zip Code : 17822-2001 |
| Country : United States |
| Facility Name : CCOP - Upstate Carolina |
| City : Spartanburg |
| State : South Carolina |
| Zip Code : 29303 |
| Country : United States |
| Facility Name : CCOP - Sioux Community Cancer Consortium |
| City : Sioux Falls |
| State : South Dakota |
| Zip Code : 57104 |
| Country : United States |
| Facility Name : Rapid City Regional Hospital |
| City : Rapid City |
| State : South Dakota |
| Zip Code : 57709 |
| Country : United States |
| OutComes |
| Primary OutComes |
| Measure : Comparison of weight gain and rate of weight change |
| Secondary OutComes |
| 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 |
| Interventions |
| Type : Biological |
| Name : etanercept |
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