Valproic Acid and Platinum-based Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma

• Status: Completed
• Trial end date: 2014-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate if the addition of valproic acid to standard platinum-based chemoradiation as definitive treatment of locally advanced Head and Neck squamous cell carcinoma can improve treatment outcomes, such as response rate.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Instituto do Cancer do Estado de São Paulo
• Collaborator: University of Sao Paulo
• Treatments: Valproic Acid

Criteria

Inclusion Criteria:

• Unresectable Oropharyngeal or oral cavity squamous cell carcinoma

• Candidate for definitive chemoradiation

• No previous treatment

• Measurable disease according to RECIST v 1.1

• Previous neoplasia, other than Head and Neck, with more than five years without evidence of disease; basocellular carcinoma of the skin and in situ cervical dysplasia if resected

• Age under 60 years

• ECOG performance status 0-2

• Ability of understanding and giving informed consent

• Adequate renal and hepatic function

• Adequate bone marrow function

• Normal serum magnesium

• Absence of QTc prolongation

• Life expectancy of over 12 weeks

Exclusion Criteria:

• Pregnancy

• Distant metastasis

• Hypersensibility to valproic acid or other antiepileptic drugs

• Valproic acid chronic use

• Severe neurologic impairment

• Uncontrolled comorbidity

• Hypoalbuminemia

• Known history of hepatitis B, C or HIV