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Valproic Acid Plus Cisplatin and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck

NCT02624128 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-11-13

No results posted yet for this study

Summary

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.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Valproic Acid

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.

DRUG

Cisplatin

administered intravenously at dose of 75 mg/m2 given every three weeks for 6 cycles

DRUG

Cetuximab

administered intravenously at induction dose of 400 mg/m2 followed by maintenance doses of 250 mg/m2 given weekly

Sponsors & Collaborators

  • National Cancer Institute, Naples

    lead OTHER

Principal Investigators

  • Francesco Caponigro, M.D · National Cancer Institute, Naples

  • Alfredo Budillon, M.D · National Cancer Institute, Naples

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-23
Primary Completion
2019-04-11
Completion
2023-12-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02624128 on ClinicalTrials.gov