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

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00046904
• Other study ID #: CDR0000257027
• Secondary ID: NCCTG-N00C1NCI-P
• Status: Completed
• Phase: Phase 3
• First received: October 3, 2002
• Last updated: May 4, 2011
• Start date: May 2003

Study information

• Verified date: May 2011
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

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

Intervention

Biological:
• etanercept

Locations

Country	Name	City	State
United States	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan
United States	Cancer Care Center at Medcenter One Hospital	Bismarck	North Dakota
United States	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa
United States	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania
United States	CCOP - Iowa Oncology Research Association	Des Moines	Iowa
United States	MBCCOP - Hawaii	Honolulu	Hawaii
United States	Mayo Clinic - Jacksonville	Jacksonville	Florida
United States	MBCCOP - Gulf Coast	Mobile	Alabama
United States	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Rapid City Regional Hospital	Rapid City	South Dakota
United States	Mayo Clinic Cancer Center	Rochester	Minnesota
United States	Mayo Clinic Scottsdale	Scottsdale	Arizona
United States	Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center	Sioux City	Iowa
United States	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota
United States	CCOP - Upstate Carolina	Spartanburg	South Carolina
United States	CCOP - Oklahoma	Tulsa	Oklahoma
United States	CCOP - Carle Cancer Center	Urbana	Illinois
United States	CCOP - Wichita	Wichita	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Cli

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 Nort — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of weight gain and rate of weight change
Secondary	Differences in appetite
Secondary	Overall survival
Secondary	Incidence of treatment-related toxicity
Secondary	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