V-CHANCE is a phase 2, trial exploring the feasibility and the activity of valproic acid (VPA) in combination with the standard cisplatin-cetuximab combination in patients with recurrent/metastatic squamous cell carcinoma of the head and neck, never treated with first-line chemotherapy. The study includes an explorative analysis of the potential prognostic or predictive role of several biomarkers with the aim of improving the knowledge of the mechanisms by which VPA enhances chemotherapy effect and of identifying early predictors of treatment response/resistance.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Treatment will be administered orally starting at day -14, with 500 mg slow releasing tablet at evening. Thereafter, the dose will be increased also using 300 mg tablets until reaching 1500 mg on day -1. The titration strategy is to reach a target VPA serum level of 50-100 μg/ml.
administered intravenously at dose of 75 mg/m2 given every three weeks for 6 cycles
administered intravenously at induction dose of 400 mg/m2 followed by maintenance doses of 250 mg/m2 given weekly
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Italy
Proportion of patients with an objective response
Response will be assessed according to RECIST v1.1 criteria
Time frame: up to 4 years
overall survival
Time frame: up to 6 years
time to tumor progression
Time frame: up to 6 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: up to 18 weeks
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