Squamous Cell Carcinoma of the Head and NeckPhase 2V-CHANCENCT02624128
Valproic Acid Plus Cisplatin and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck
A Phase 2 study testing Valproic Acid, Cisplatin and Cetuximab in people with Squamous Cell Carcinoma of the Head and Neck, run by National Cancer Institute, Naples at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Valproic Acid, Cisplatin and Cetuximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteItaly
- Study dates
- 23 Feb 2015to Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Keywords
- head and neck cancer, valproic acid, recurrent, metastatic
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valproic AcidDrug
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.
CisplatinDrug
administered intravenously at dose of 75 mg/m2 given every three weeks for 6 cycles
CetuximabDrug
administered intravenously at induction dose of 400 mg/m2 followed by maintenance doses of 250 mg/m2 given weekly
| Study group | Role | What they receive |
|---|---|---|
| valproic acid plus cisplatin and cetuximab | Experimental | Not described Receives: Drug: Valproic Acid; Drug: Cisplatin; Drug: Cetuximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with an objective response
Response will be assessed according to RECIST v1.1 criteria
Measured: up to 4 years
Secondary outcomes (3)
overall survival
Measured: up to 6 years
time to tumor progression
Measured: up to 6 years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
- Study start23 Feb 2015
- Primary completion11 Apr 2019
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Caponigro, M.D, Principal investigator, National Cancer Institute, NaplesAlfredo Budillon, M.D, Principal investigator, National Cancer Institute, Naples
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624128
- Sponsor's protocol ID
- V-CHANCE
- Other IDs
- 2014-001523-69, 2014
- Acronym
- V-CHANCE
- Status last verified
- Mar 2023
- First submitted
- 26 Nov 2015
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Caponigro F, Di Gennaro E, Ionna F, Longo F, Aversa C, Pavone E, Maglione MG, Di Marzo M, Muto P, Cavalcanti E, Petrillo A, Sandomenico F, Maiolino P, D'Aniello R, Botti G, De Cecio R, Losito NS, Scala S, Trotta A, Zotti AI, Bruzzese F, Daponte A, Calogero E, Montano M, Pontone M, De Feo G, Perri F, Budillon A. Phase II clinical study of valproic acid plus cisplatin and cetuximab in recurrent and/or metastatic squamous cell carcinoma of Head and Neck-V-CHANCE trial. BMC Cancer. 2016 Nov 25;16(1):918. doi: 10.1186/s12885-016-2957-y.
PubMed 27884140
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02624128
- Acronym / sponsor ID
- V-CHANCE / V-CHANCE
- Keywords
- head and neck cancer, valproic acid, recurrent, metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- National Cancer Institute, NaplesUniversity, hospital or other
- Study start
- 23 Feb 2015 (actual)
- Primary completion
- 11 Apr 2019 (actual)
- Study completion
- Dec 2023 (estimated)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| valproic acid plus cisplatin and cetuximab | Experimental | Drug: Valproic Acid, Drug: Cisplatin, Drug: Cetuximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valproic AcidTreatment 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 | valproic acid plus cisplatin and cetuximab |
| Cisplatinadministered intravenously at dose of 75 mg/m2 given every three weeks for 6 cycles | Drug | valproic acid plus cisplatin and cetuximab |
| Cetuximabadministered intravenously at induction dose of 400 mg/m2 followed by maintenance doses of 250 mg/m2 given weekly | Drug | valproic acid plus cisplatin and cetuximab |
Primary outcome
Proportion of patients with an objective response
Time frame: up to 4 years
Response will be assessed according to RECIST v1.1 criteria
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 27884140Caponigro F, Di Gennaro E, Ionna F, Longo F, Aversa C, Pavone E, Maglione MG, Di Marzo M, Muto P, Cavalcanti E, Petrillo A, Sandomenico F, Maiolino P, D'Aniello R, Botti G, De Cecio R, Losito NS, Scala S, Trotta A, Zotti AI, Bruzzese F, Daponte A, Calogero E, Montano M, Pontone M, De Feo G, Perri F, Budillon A. Phase II clinical study of valproic acid plus cisplatin and cetuximab in recurrent and/or metastatic squamous cell carcinoma of Head and Neck-V-CHANCE trial. BMC Cancer. 2016 Nov 25;16(1):918. doi: 10.1186/s12885-016-2957-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Caponigro, M.D principal investigator
National Cancer Institute, Naples
Alfredo Budillon, M.D principal investigator
National Cancer Institute, Naples
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valproic Acid, Cisplatin and Cetuximab in people with Squamous Cell Carcinoma of the Head and Neck, run by National Cancer Institute, Naples at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with an objective response (time frame: up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02624128, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.