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Phase III Placebo-Controlled, Randomized, Double-Blind Comparison Of Etanercept (Enbrel) Versus Placebo For The Treatment Of Cancer-Associated Weight Loss And Anorexia

Phase 3
18 Years
Not Enrolling
Anorexia, Cachexia, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

Trial Information

Phase III Placebo-Controlled, Randomized, Double-Blind Comparison Of Etanercept (Enbrel) Versus Placebo For The Treatment Of Cancer-Associated Weight Loss And Anorexia


- 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

- 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

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.

Inclusion Criteria


- 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

- Weight gain determined by physician to be beneficial

- Patient perceives weight loss as a problem



- 18 and over

Performance status

- ECOG 0-2

Life expectancy

- More than 3 months


- Not specified


- Not specified


- Not specified


- 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


- 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


- 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


Biologic therapy

- More than 1 month since prior infliximab

- No concurrent live vaccination


- 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


- Concurrent radiotherapy allowed


- Not specified


- 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)

Type of Study:


Study Design:

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

Outcome Measure:

Comparison of weight gain and rate of weight change

Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

May 2003

Completion Date:

Related Keywords:

  • Anorexia
  • Cachexia
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • anorexia
  • cachexia
  • Anorexia
  • Cachexia



Mayo Clinic Scottsdale Scottsdale, Arizona  85259
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
MBCCOP - Hawaii Honolulu, Hawaii  96813
CCOP - Upstate Carolina Spartanburg, South Carolina  29303
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
MBCCOP - Gulf Coast Mobile, Alabama  36688
CCOP - Oklahoma Tulsa, Oklahoma  74136
Cancer Care Center at Medcenter One Hospital Bismarck, North Dakota  58501
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center Sioux City, Iowa  51101