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Chidamide Combined With Cisplatin in Head and Neck Adenoid Cystic Carcinoma (HNACC)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03639168
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Kai Xue, MD, Fudan University

Tracking Information
First Submitted Date  ICMJE August 4, 2018
First Posted Date  ICMJE August 21, 2018
Last Update Posted Date August 22, 2018
Actual Study Start Date  ICMJE June 6, 2018
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
Overall response rate (ORR) [ Time Frame: 6 weeks ]
Defined as numbers of patients achieved complete response and patial response of treatment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03639168 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2018)
  • Disease control rate (DCR) [ Time Frame: 6 weeks ]
    Defined as numbers of patients achieved complete response, patial response, and stable disease of treatment
  • Progression-free survival (PFS) [ Time Frame: 6 weeks ]
    Defined as the time from randomization until objective tumor progression or death
  • Scoring of quality of life: EORTC-30 [ Time Frame: 6 weeks ]
    Quality of life evaluated using EORTC-30, the summed scores will be recorded.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2018)
  • Disease control rate (DCR) [ Time Frame: 6 weeks ]
    Defined as numbers of patients achieved complete response, patial response, and stable disease of treatment
  • Progression-free survival (PFS) [ Time Frame: 6 weeks ]
    Defined as the time from randomization until objective tumor progression or death
  • Scoring of quality of life [ Time Frame: 6 weeks ]
    Quality of life evaluated using EORTC-30
Current Other Pre-specified Outcome Measures
 (submitted: August 16, 2018)
Serum ctDNA biomarker [ Time Frame: throughout the treatment period,up to 6 months ]
relationship between biomarker and treatment outcome
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Chidamide Combined With Cisplatin in Head and Neck Adenoid Cystic Carcinoma (HNACC)
Official Title  ICMJE Chidamide Combined With Cisplatin in Recurrent or Metastatic Head and Neck Adenoid Cystic Carcinoma: A Prospective, Open-label, Phase II Study of a Single Center
Brief Summary The investigators conducted this study to evaluate the efficacy of Chidamide combined with cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma.
Detailed Description Adenoid cystic carcinomas (ACCs) constitute of 1% of head and neck cancers. This type of tumor grows slowly with a high potential of local recurrence. Approximately 50% of patients develop distant metastases, and 33% patients die within 2 years. The initial therapy of these malignancies consists of surgical resection followed by radiotherapy. Systemic therapy is crucial in the management of recurrent and metastatic disease. However, nowadays, there were no standard chemoimmunotherapy regimes. Previous report showed that overall response rate was only less than 10% using single-agent chemotherapies, and the best results were achieved by cisplatin. Chidamide is a new benzamide class of histone deacetylase inhibitor with marked antitumor activity. And a phase I study has showed that one of three patients with submandibular adenoid cystic carcinoma achieved a partial response treated with Chidamide. The investigators conducted this study to evaluate the efficacy of Chidamide combined with cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma, in order to find a potential promising way to treat this kind of disease.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Adenoid Cystic Carcinomas
  • Chidamide
  • Cisplatin
Intervention  ICMJE Drug: Chidamide combined with cisplatin
Chidamide combined with cisplatin
Study Arms  ICMJE Experimental: Chidamide combined with Cisplatin
Chidamide: 30mg,PO,biw one week before cycle 1 treatment Cisplatin 25mg/m2 ivgtt D1-3 Chidamide :20mg PO Biw, 2 week on , 1 week off
Intervention: Drug: Chidamide combined with cisplatin
Publications * Not Provided

*   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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 16, 2018)
22
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date June 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age range 18-75 years old
  2. Histological confirmed recurrent or metastatic head and neck adenoid cystic carcinoma
  3. Unable to treat with surgery/radiotherapy, or previously failure to non-cisplatin systematic treatment;
  4. Eastern Cooperative Oncology Group performance status 0 to 2;
  5. Patients have written informed consent to participate in the study;
  6. anticipated to live ≧3 months;
  7. Absolute neutrophil count ≥ 1.5×109/L,platelet ≥ 100×109/L,hemoglobin ≥ 90 g/L
  8. total bilirubin < 1.5×upper limit of normal(ULN), ALT and AST < 3× ULN
  9. serum creatine <1.5×ULN, and creatinine clearance rate (CCR) ≥ 50 ml/min
  10. Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed no signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
  11. Measurable disease was defined as at least one lesion ≥1.5 cm in length-diameter and ≥0.5 cm in short-diameter by CT.

Exclusion Criteria:

  1. Previously treated with HDACi;
  2. Treated with cisplatin-contained regimes in the past half of the year, and not achieving PR/CR;
  3. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix;
  4. HIV, HCV, or syphilis infection;
  5. Pregnant or lactating women;
  6. Serious uncontrolled infection;
  7. Severe neurol of mental illness, including dementia and epilepsy;
  8. Having contraindications to the use of oral medication, such as unable to swallow, nausea and vomiting, chronic diarrhea or suffering from a bowel obstruction;
  9. Participated in other clinical trials in 4 weeks;
  10. Other coexisting diseases or situations that may cause patients to fail to complete clinical trials;
  11. History of QTc interval prolongation (Male >450ms,Female >470ms), ventricular tachycardia, auricular fibrillation, heart block of more than II degrees, myocardial infarction in 1 year, congenital heart disease, with symptomatic coronary heart disease requiring medication.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kai Xue, MD 021-64175590 xuekaishanghai@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03639168
Other Study ID Numbers  ICMJE CC-HN-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kai Xue, MD, Fudan University
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kai Xue, MD Department of medical oncology,Fudan University, Shanghai Cancer Center
PRS Account Fudan University
Verification Date August 2018

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