Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase III Placebo-Controlled, Randomized, Double-Blind Comparison Of Etanercept (Enbrel) Versus Placebo For The Treatment Of Cancer-Associated Weight Loss And Anorexia

Conditions
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Anorexia, Cachexia, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Biological: etanercept


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: etanercept|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of weight gain and rate of weight change |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific, anorexia, cachexia