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

NCT00046904 | Completed Phase 3 DMC

• 5 other identifiers: CDR0000257027NCCTG-N00C1NCI-P02-0232MC00C81497-00
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 19

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.

Conditions

Anorexia; Cachexia; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific; anorexia; cachexia

Outcome Measures

Primary Outcomes (1)

• Comparison of weight gain and rate of weight change

Secondary Outcomes (4)

• 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

Interventions

etanercept BIOLOGICAL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (19)

MBCCOP - Gulf Coast

Mobile, Alabama, 36607, United States

Location

Mayo Clinic Scottsdale

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224, United States

Location

MBCCOP - Hawaii

Honolulu, Hawaii, 96813, United States

Location

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61615-7828, United States

Location

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

Location

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

Location

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1854, United States

Location

Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center

Sioux City, Iowa, 51101-1733, United States

Location

CCOP - Wichita

Wichita, Kansas, 67214-3882, United States

Location

CCOP - Michigan Cancer Research Consortium

Ann Arbor, Michigan, 48106, United States

Location

Mayo Clinic Cancer Center

Rochester, Minnesota, 55905, United States

Location

CCOP - Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Cancer Care Center at Medcenter One Hospital

Bismarck, North Dakota, 58501-5505, United States

Location

CCOP - Oklahoma

Tulsa, Oklahoma, 74136, United States

Location

CCOP - Geisinger Clinic and Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303, United States

Location

Rapid City Regional Hospital

Rapid City, South Dakota, 57709, United States

Location

CCOP - Sioux Community Cancer Consortium

Sioux Falls, South Dakota, 57104, United States

Location

Related Publications (2)

• 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.

  PMID: 17674351 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Anorexia; Cachexia

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Thinness

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Officials

• Aminah Jatoi, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SUPPORTIVE CARE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 3, 2002
• First Posted: January 27, 2003
• Study Start: May 1, 2003
• Primary Completion: September 1, 2007
• Last Updated: May 5, 2011

Record last verified: 2011-05

Locations

US (19)