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

Phase 3

Completed

• Conditions: Cachexia; Unspecified Adult Solid Tumor, Protocol Specific; Anorexia

• Registration Number: NCT00046904
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2002-10-03
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Study Start: 2003-05
• Primary Completion: 2007-09
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-04
• Last Update Posted: 2011-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of weight gain and rate of weight change

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (19)

Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center; 🇺🇸 Sioux City, Iowa, United States

CCOP - Upstate Carolina; 🇺🇸 Spartanburg, South Carolina, United States

Mayo Clinic Scottsdale; 🇺🇸 Scottsdale, Arizona, United States

CCOP - Carle Cancer Center; 🇺🇸 Urbana, Illinois, United States

CCOP - Cedar Rapids Oncology Project; 🇺🇸 Cedar Rapids, Iowa, United States

CCOP - Oklahoma; 🇺🇸 Tulsa, Oklahoma, United States

MBCCOP - Gulf Coast; 🇺🇸 Mobile, Alabama, United States

Mayo Clinic Cancer Center; 🇺🇸 Rochester, Minnesota, United States

CCOP - Missouri Valley Cancer Consortium; 🇺🇸 Omaha, Nebraska, United States

CCOP - Illinois Oncology Research Association; 🇺🇸 Peoria, Illinois, United States

Mayo Clinic - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

CCOP - Wichita; 🇺🇸 Wichita, Kansas, United States

Cancer Care Center at Medcenter One Hospital; 🇺🇸 Bismarck, North Dakota, United States

MBCCOP - Hawaii; 🇺🇸 Honolulu, Hawaii, United States

CCOP - Iowa Oncology Research Association; 🇺🇸 Des Moines, Iowa, United States

CCOP - Michigan Cancer Research Consortium; 🇺🇸 Ann Arbor, Michigan, United States

Rapid City Regional Hospital; 🇺🇸 Rapid City, South Dakota, United States

CCOP - Geisinger Clinic and Medical Center; 🇺🇸 Danville, Pennsylvania, United States

CCOP - Sioux Community Cancer Consortium; 🇺🇸 Sioux Falls, South Dakota, United States