Phase III Placebo-Controlled, Randomized, Double-Blind Comparison Of Etanercept (Enbrel) Versus Placebo For The Treatment Of Cancer-Associated Weight Loss And Anorexia
18 Years
N/A
Both
Anorexia, Cachexia, Unspecified Adult Solid Tumor, Protocol Specific
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
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.
Inclusion 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)
Type of Study:
Interventional
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
Authority:
United States: Federal Government
Study ID:
CDR0000257027
NCT ID:
NCT00046904
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
Name | Location |
|---|---|
| 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 |
