Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Completed	18 and over	NCI	NCCTG-N00C1 NCI-P02-0232, N00C1, NCT00046904

Objectives

1. 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.
2. Determine the effect of this drug on nausea and vomiting in these patients.
3. Assess the functional status and appetite of patients treated with this drug.
4. Assess the quality of life of patients treated with this drug.
5. Determine the toxic effects of this drug in these patients.
6. Determine whether this drug prolongs survival of these patients.

Entry 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

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)

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

Expected Enrollment

A total of 274 patients (137 per treatment arm) will be accrued for this study within 19 months.

Outcomes

Comparison of weight gain and rate of weight change

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

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.

Jatoi A, Dakhil SR, Nguyen PL, et al.: 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 110 (6): 1396-403, 2007.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Aminah Jatoi, MD, Protocol chair		Ph: 507-284-4918

Registry Information
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
Trial Start Date		2003-05-27
Trial Completion Date		2007-09-15
Registered in ClinicalTrials.gov		NCT00046904
Date Submitted to PDQ		2002-08-01
Information Last Verified		2006-10-23

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