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Trial record 1 of 1 for:    v-chance
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Valproic Acid Plus Cisplatin and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck (V-CHANCE)

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute, Naples

Tracking Information
First Submitted Date  ICMJE November 26, 2015
First Posted Date  ICMJE December 8, 2015
Last Update Posted Date March 29, 2017
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
Proportion of patients with an objective response [ Time Frame: up to 4 years ]
Response will be assessed according to RECIST v1.1 criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Valproic Acid Plus Cisplatin and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck
Official Title  ICMJE Preclinical and Clinical Study of Valproic Acid Plus Cisplatin and Cetuximab in Recurrent and/or Metastatic Squamous Cell Carcinoma of Head and Neck
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Squamous Cell Carcinoma of the Head and Neck
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: valproic acid plus cisplatin and cetuximab
Interventions:
  • Drug: Valproic Acid
  • Drug: Cisplatin
  • Drug: Cetuximab
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 7, 2015)
39
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2019
Estimated Primary Completion Date February 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02624128
Other Study ID Numbers  ICMJE V-CHANCE
2014-001523-69 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Cancer Institute, Naples
Study Sponsor  ICMJE National Cancer Institute, Naples
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francesco Caponigro, M.D National Cancer Institute, Naples
Principal Investigator: Alfredo Budillon, M.D National Cancer Institute, Naples
PRS Account National Cancer Institute, Naples
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP