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

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00046904

Purpose

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	Intervention	Phase
Anorexia Cachexia Unspecified Adult Solid Tumor, Protocol Specific	Biological: etanercept	Phase III

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Weight Control

Drug Information available for: Etanercept

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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

Study Start Date:	May 2003
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046904

Locations

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

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Aminah Jatoi, MD

Mayo Clinic

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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 North Central Cancer Treatment Group. Cancer. 2007 Aug 2; [Epub ahead of print]

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.

Study ID Numbers:	CDR0000257027, NCCTG-N00C1, NCI-P02-0232
Study First Received:	October 3, 2002
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00046904 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

unspecified adult solid tumor, protocol specific
anorexia
cachexia

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Signs and Symptoms, Digestive
Physiological Effects of Drugs
Gastrointestinal Agents
Cachexia
Emaciation
TNFR-Fc fusion protein
Immunosuppressive Agents
Pharmacologic Actions
Body Weight
Signs and Symptoms

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Weight Loss
Anorexia
Body Weight Changes
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009