Overview

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