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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00046904
First received: October 3, 2002
Last updated: May 4, 2011
Last verified: May 2011
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615-7828
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
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
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57709
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, United States, 57104
Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Aminah Jatoi, MD Mayo Clinic
  More Information

Additional Information:
Publications:
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.

Responsible Party: Aminah Jatoi, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00046904     History of Changes
Other Study ID Numbers: CDR0000257027, NCCTG-N00C1, NCI-P02-0232, MC00C8, 1497-00
Study First Received: October 3, 2002
Last Updated: May 4, 2011
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
unspecified adult solid tumor, protocol specific
anorexia
cachexia

Additional relevant MeSH terms:
Anorexia
Cachexia
Signs and Symptoms, Digestive
Signs and Symptoms
Emaciation
Weight Loss
Body Weight Changes
Body Weight
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 21, 2014