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

Brief Title

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

Official Title

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Overall response rate (ORR)

Secondary Outcome

 Disease control rate (DCR)

Condition

Adenoid Cystic Carcinomas

Intervention

Chidamide combined with cisplatin

Study Arms / Comparison Groups

 Chidamide combined with Cisplatin

Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

22

Start Date

June 6, 2018

Completion Date

June 1, 2020

Primary Completion Date

March 1, 2020

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Kai Xue, MD, 021-64175590, [email protected]

Location Countries

China

Location Countries

China

NCT ID

NCT03639168

Organization ID

CC-HN-1

Responsible Party

Principal Investigator

Study Sponsor

Fudan University

Study Sponsor

Kai Xue, MD, Principal Investigator, Department of medical oncology,Fudan University, Shanghai Cancer Center

Verification Date

February 2020