Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
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
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.
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.
;
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
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