Recurrent and/or metastatic squamous cell carcinoma of head and neck MedDRA version: 17.0 Level: PT Classification code 10067821 Term: Head and neck cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Valproic Acid
Product Name: Valproic Acid
Product Code: NA
Pharmaceutical Form: Buccal tablet
INN or Proposed INN: VALPROIC ACID
CAS Number: 99-66-1
Concentration unit: mg milligram(s)
Con
Sponsors
Istituto Nazionale Tumori di Napoli - Fondazione "G. Pascale"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically or cytologically proven HPV negative squamous cell carcinoma of head and neck with the exclusion of nasopharyngeal cancer 2.First-line recurrent and/or metastatic disease 3.No prior chemotherapy except for chemoradiation or induction chemotherapy followed by local treatment given in the context of a curative strategy. 4.age> 18 years 5.ECOG Performance Status =1 6.Life expectancy at least 3 months at study entrance 7.Normal bone marrow reserve (absolute neuthrophil count > 1500/mm3; platelets > 100000/mm3; haemoglobin> 9 g/dl) 8.Normal hepatic function (total serum bilirubin 60 ml/min). 10.Normal cardiac function (assessed by ECG and ecocardiography with ejection fraction > 50%) 11.Effective contraception for both male and female patients if the risk of conception exists. 12.Signed written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 9
Exclusion criteria
Exclusion criteria: 1. Concomitant treatment with other experimental drugs. 2. Brain metastases (CT scan or MRI required only in case of clinical suspicion of CNS metastases) 3. Non squamous cell histology 4. Any concurrent malignancy. Patients with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial. 5. History of myocardial infarction within the last 12 months 6. ECOG PS = 2 7. Significant cardiovascular comorbidity (e.g. myocardial infarction, superior vena cava [SVC] syndrome, patients with an ejection fraction of 480 msec or concomitant medication with drugs prolonging QTc. 9. HIV positive patients 10. Patients who cannot take oral medication, who require intravenous feeding, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease. 11. Known or suspected hypersensitivity to any of the study drugs. 12. Patients who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid. 13. Major surgical procedure, within 28 days prior to study treatment start. 14. Pregnant or lactating women. 15. Women of childbearing potential with either a positive or no pregnancy test at baseline (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential). 16. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to progression, duration of response and overall survival will be calculated from the first treatment day until the day of event occurrence;Timepoint(s) of evaluation of this end point: from the first treatment day until the day of event occurrence | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore in a phase 2 trial whether the addition of valproic acid to the standard cisplatin-cetuximab combination can improve treatment activity (in terms of objective response rate) in patients with recurrent/metastatic non pretreated SCCHN;Secondary Objective: •To evaluate the impact of the experimental schedule on: •Time to progression •Overallsurvival (OS). •Toxicity. •Quality of life •ParallelPreclinicalstudy •Biomarker studies on tumor and blood samples ;Primary end point(s): The overall response rate;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Italy
Contacts
Public ContactFrancesco Caponigro
Istituto Nazionale Tumori di Napoli - Fondazione "G. Pascale"
Outcome results
None listed