- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02624128
Valproic Acid Plus Cisplatin and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck (V-CHANCE)
March 23, 2023 updated by: National Cancer Institute, Naples
Preclinical and Clinical Study of Valproic Acid Plus Cisplatin and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck
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 Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
39
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Napoli, Italy
- Istituto Nazionale Tumori Fondazione G. Pascale
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically or cytologically proven squamous cell carcinoma of head and neck with exclusion of the nasopharynx
- First-line recurrent and/or metastatic disease
- No prior chemotherapy except for chemoradiation or induction chemotherapy followed by local treatment given in the context of a curative strategy.
- age> 18 years
- ECOG Performance Status ≤1
- Life expectancy at least 3 months at study entrance
- Normal bone marrow reserve (absolute neutrophil count > 1500/mm3; platelets > 100000/mm3; haemoglobin> 9 g/dl)
- Normal hepatic function (total serum bilirubin < 1.5 x upper limit of normal; liver transaminases < 3 x upper limit of normal)
- Normal renal function (serum creatinine < 1,25 x upper limit of normal and creatinine clearance > 60 ml/min).
- Normal cardiac function (assessed by ECG and echocardiography with ejection fraction > 50%)
- Effective contraception for both male and female patients if the risk of conception exist
- Signed written informed consent
Exclusion Criteria:
- Concomitant treatment with other experimental drugs.
- Brain metastases (CT scan or MRI required only in case of clinical suspicion of CNS metastases)
- Non squamous cell histology
- Any concurrent malignancy. Patient with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial.
- History of myocardial infarction within the last 12 months
- ECOG PS ≥ 2
- 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.
- 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.
- HIV positive patients
- Patients who cannot take oral medication, who require intravenous feeding, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.
- Known or suspected hypersensitivity to any of the study drugs.
- 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.
- Major surgical procedure within 28 days prior to study treatment start.
- Pregnant or lactating women.
- 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.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: valproic acid plus cisplatin and cetuximab
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of patients with an objective response
Time Frame: up to 4 years
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Response will be assessed according to RECIST v1.1 criteria
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up to 4 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: up to 6 years
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up to 6 years
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time to tumor progression
Time Frame: up to 6 years
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up to 6 years
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Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: up to 18 weeks
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up to 18 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Francesco Caponigro, M.D, National Cancer Institute, Naples
- Principal Investigator: Alfredo Budillon, M.D, National Cancer Institute, Naples
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 23, 2015
Primary Completion (Actual)
April 11, 2019
Study Completion (Anticipated)
May 1, 2023
Study Registration Dates
First Submitted
November 26, 2015
First Submitted That Met QC Criteria
December 7, 2015
First Posted (Estimate)
December 8, 2015
Study Record Updates
Last Update Posted (Actual)
March 24, 2023
Last Update Submitted That Met QC Criteria
March 23, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Head and Neck Neoplasms
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Squamous Cell Carcinoma of Head and Neck
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Tranquilizing Agents
- Psychotropic Drugs
- GABA Agents
- Anticonvulsants
- Antimanic Agents
- Valproic Acid
- Cetuximab
Other Study ID Numbers
- V-CHANCE
- 2014-001523-69 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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