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

Sponsor

Mayo Clinic (Other)

Overall Status

Completed

CT.gov ID

NCT00046904

Collaborator

National Cancer Institute (NCI) (NIH)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anorexia Cachexia Unspecified Adult Solid Tumor, Protocol Specific	Biological: etanercept	Phase 3

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Masking:

Double

Primary Purpose:

Supportive Care

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

Study Start Date :

May 1, 2003

Actual Primary Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

Comparison of weight gain and rate of weight change []

Secondary Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MBCCOP - Gulf Coast	Mobile	Alabama	United States	36607
2	Mayo Clinic Scottsdale	Scottsdale	Arizona	United States	85259
3	Mayo Clinic - Jacksonville	Jacksonville	Florida	United States	32224
4	MBCCOP - Hawaii	Honolulu	Hawaii	United States	96813
5	CCOP - Illinois Oncology Research Association	Peoria	Illinois	United States	61615-7828
6	CCOP - Carle Cancer Center	Urbana	Illinois	United States	61801
7	CCOP - Cedar Rapids Oncology Project	Cedar Rapids	Iowa	United States	52403-1206
8	CCOP - Iowa Oncology Research Association	Des Moines	Iowa	United States	50309-1854
9	Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center	Sioux City	Iowa	United States	51101-1733
10	CCOP - Wichita	Wichita	Kansas	United States	67214-3882
11	CCOP - Michigan Cancer Research Consortium	Ann Arbor	Michigan	United States	48106
12	Mayo Clinic Cancer Center	Rochester	Minnesota	United States	55905
13	CCOP - Missouri Valley Cancer Consortium	Omaha	Nebraska	United States	68106
14	Cancer Care Center at Medcenter One Hospital	Bismarck	North Dakota	United States	58501-5505
15	CCOP - Oklahoma	Tulsa	Oklahoma	United States	74136
16	CCOP - Geisinger Clinic and Medical Center	Danville	Pennsylvania	United States	17822-2001
17	CCOP - Upstate Carolina	Spartanburg	South Carolina	United States	29303
18	Rapid City Regional Hospital	Rapid City	South Dakota	United States	57709
19	CCOP - Sioux Community Cancer Consortium	Sioux Falls	South Dakota	United States	57104