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

Primary Purpose

Anorexia, Cachexia, Unspecified Adult Solid Tumor, Protocol Specific

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
etanercept
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anorexia focused on measuring unspecified adult solid tumor, protocol specific, anorexia, cachexia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • MBCCOP - Gulf Coast
  • Mayo Clinic Scottsdale
  • Mayo Clinic - Jacksonville
  • MBCCOP - Hawaii
  • CCOP - Illinois Oncology Research Association
  • CCOP - Carle Cancer Center
  • CCOP - Cedar Rapids Oncology Project
  • CCOP - Iowa Oncology Research Association
  • Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
  • CCOP - Wichita
  • CCOP - Michigan Cancer Research Consortium
  • Mayo Clinic Cancer Center
  • CCOP - Missouri Valley Cancer Consortium
  • Cancer Care Center at Medcenter One Hospital
  • CCOP - Oklahoma
  • CCOP - Geisinger Clinic and Medical Center
  • CCOP - Upstate Carolina
  • Rapid City Regional Hospital
  • CCOP - Sioux Community Cancer Consortium

Outcomes

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

Full Information

First Posted
October 3, 2002
Last Updated
May 4, 2011
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00046904
Brief Title
Etanercept in Treating Cancer-Related Cachexia and Anorexia in Patients With Advanced Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia, Cachexia, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
unspecified adult solid tumor, protocol specific, anorexia, cachexia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
etanercept
Primary Outcome Measure Information:
Title
Comparison of weight gain and rate of weight change
Secondary Outcome Measure Information:
Title
Differences in appetite
Title
Overall survival
Title
Incidence of treatment-related toxicity
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aminah Jatoi, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
MBCCOP - Gulf Coast
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36607
Country
United States
Facility Name
Mayo Clinic Scottsdale
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Mayo Clinic - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
MBCCOP - Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
CCOP - Illinois Oncology Research Association
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61615-7828
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Cedar Rapids Oncology Project
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403-1206
Country
United States
Facility Name
CCOP - Iowa Oncology Research Association
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309-1854
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101-1733
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214-3882
Country
United States
Facility Name
CCOP - Michigan Cancer Research Consortium
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CCOP - Missouri Valley Cancer Consortium
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Cancer Care Center at Medcenter One Hospital
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501-5505
Country
United States
Facility Name
CCOP - Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
CCOP - Geisinger Clinic and Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-2001
Country
United States
Facility Name
CCOP - Upstate Carolina
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Rapid City Regional Hospital
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57709
Country
United States
Facility Name
CCOP - Sioux Community Cancer Consortium
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17674351
Citation
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 Sep 15;110(6):1396-403. doi: 10.1002/cncr.22944.
Results Reference
result
Citation
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.
Results Reference
result

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

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