HCC Clinical Trial
Official title:
A Randomized, Double Blind, Placebo Controlled, Multicenter Phase 2 Study of VT-122 in Combination With Sorafenib Compared to Sorafenib With Placebo in Patients With Hepatocellular Carcinoma and Systemic Inflammation at Risk for Cachexia
The purpose of this study is to determine if VT-122 provides a clinical benefit when added to Sorafenib in patients with advanced hepatocellular carcinoma (HCC).
The most common clinical course of the patient with cancer is local tumor progression
leading to the development of metastases, systemic inflammation and the ensuing symptom
cluster known as anorexia-cachexia syndrome. This syndrome includes cachexia (anorexia,
weight loss and muscle wasting), fatigue, weakness, pain, dyspnea, nausea, malaise,
depression and poor performance status. Patients suffering from this syndrome also have poor
tolerance, adherence and response to anti-cancer therapy, resulting in disease progression
and reduced life expectancy. In spite of the dire need, no proven options for treating
inflammatory cancer cachexia are currently available.
VT-122 is the co-administration of the cyclo-oxygenase 2 (COX-2) inhibitor, etodolac and the
beta-adrenergic antagonist, propranolol.
It is proposed that these drugs can attenuate systemic inflammation and ameliorate the
symptoms of inflammatory cachexia in patients with advanced cancer. As a result, this
treatment may improve tolerability and adherence to anti-cancer therapy, thereby yielding
direct and indirect benefits in reducing disease progression and improving both the life
expectancy and quality of life for patients with advanced cancer.
The potentially synergistic activities of beta blockers and COX-2 inhibitors, their
offsetting side effects and their known beneficial impact on co-morbidities associated with
liver failure may make them well-suited for use with sorafenib, the standard of care for
patients with advanced HCC.
The purpose of this study is to assess whether use of VT-122 is safe and effective in
cachectic patients with advanced HCC. In addition to assessing cachexia-related symptoms,
the ability of the VT-122 regimen to improve tolerability to sorafenib and thereby to
improve both survival and quality of life will also be assessed.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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