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Valproic Acid Plus Cisplatin and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck (V-CHANCE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02624128
Recruitment Status : Unknown
Verified March 2017 by National Cancer Institute, Naples.
Recruitment status was:  Recruiting
First Posted : December 8, 2015
Last Update Posted : March 29, 2017
Information provided by (Responsible Party):
National Cancer Institute, Naples

Brief 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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Drug: Valproic Acid Drug: Cisplatin Drug: Cetuximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preclinical and Clinical Study of Valproic Acid Plus Cisplatin and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck
Study Start Date : February 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : October 2019

Arm Intervention/treatment
Experimental: valproic acid plus cisplatin and cetuximab 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

Primary Outcome Measures :
  1. Proportion of patients with an objective response [ Time Frame: up to 4 years ]
    Response will be assessed according to RECIST v1.1 criteria

Secondary Outcome Measures :
  1. overall survival [ Time Frame: up to 6 years ]
  2. time to tumor progression [ Time Frame: up to 6 years ]
  3. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: up to 18 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Histologically or cytologically proven squamous cell carcinoma of head and neck with exclusion of the nasopharynx
  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 neutrophil count > 1500/mm3; platelets > 100000/mm3; haemoglobin> 9 g/dl)
  8. Normal hepatic function (total serum bilirubin < 1.5 x upper limit of normal; liver transaminases < 3 x upper limit of normal)
  9. Normal renal function (serum creatinine < 1,25 x upper limit of normal and creatinine clearance > 60 ml/min).
  10. Normal cardiac function (assessed by ECG and echocardiography with ejection fraction > 50%)
  11. Effective contraception for both male and female patients if the risk of conception exist
  12. Signed written informed consent

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. Patient 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 <50%) or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
  8. History of arrhythmia (multifocal premature ventricular contractions [PVCs], bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia. Patients with long QT-syndrome or QTc interval duration > 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)l.
  16. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02624128

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Contact: Francesco Caponigro, M.D. +39 081 5903362
Contact: Alfredo Budillon, M.D. +39 081 5903292

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Istituto Nazionale Tumori Fondazione G. Pascale Recruiting
Napoli, Italy
Sponsors and Collaborators
National Cancer Institute, Naples
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Principal Investigator: Francesco Caponigro, M.D National Cancer Institute, Naples
Principal Investigator: Alfredo Budillon, M.D National Cancer Institute, Naples
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: National Cancer Institute, Naples Identifier: NCT02624128    
Other Study ID Numbers: V-CHANCE
2014-001523-69 ( EudraCT Number )
First Posted: December 8, 2015    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017
Keywords provided by National Cancer Institute, Naples:
head and neck cancer
valproic acid
Additional relevant MeSH terms:
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Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Neoplasms by Site
Valproic Acid
Antineoplastic Agents
Antineoplastic Agents, Immunological
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs