Back to resultsChidamide Combined With Cisplatin in Head and Neck Adenoid Cystic Carcinoma (HNACC)
Primary Purpose
Adenoid Cystic Carcinomas, Cisplatin
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Chidamide combined with cisplatin
Sponsored by
About this trial
This is an interventional treatment trial for Adenoid Cystic Carcinomas
Eligibility Criteria
Inclusion Criteria:
- Age range 18-75 years old
- Histological confirmed recurrent or metastatic head and neck adenoid cystic carcinoma
- Unable to treat with surgery/radiotherapy, or previously failure to non-cisplatin systematic treatment;
- Eastern Cooperative Oncology Group performance status 0 to 2;
- Patients have written informed consent to participate in the study;
- anticipated to live ≧3 months;
- Absolute neutrophil count ≥ 1.5×109/L，platelet ≥ 100×109/L，hemoglobin ≥ 90 g/L
- total bilirubin < 1.5×upper limit of normal(ULN), ALT and AST < 3× ULN
- serum creatine <1.5×ULN, and creatinine clearance rate (CCR) ≥ 50 ml/min
- Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed no signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
- 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:
- Previously treated with HDACi;
- Treated with cisplatin-contained regimes in the past half of the year, and not achieving PR/CR;
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix;
- HIV, HCV, or syphilis infection；
- Pregnant or lactating women;
- Serious uncontrolled infection;
- Severe neurol of mental illness, including dementia and epilepsy;
- Having contraindications to the use of oral medication, such as unable to swallow, nausea and vomiting, chronic diarrhea or suffering from a bowel obstruction;
- Participated in other clinical trials in 4 weeks;
- Other coexisting diseases or situations that may cause patients to fail to complete clinical trials;
- 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.
Sites / Locations
- Kai Xue
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Chidamide combined with Cisplatin
Arm 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
Outcomes
Primary Outcome Measures
Overall response rate (ORR)
Defined as numbers of patients achieved complete response and patial response of treatment
Secondary Outcome Measures
Disease control rate (DCR)
Defined as numbers of patients achieved complete response, patial response, and stable disease of treatment
Progression-free survival (PFS)
Defined as the time from randomization until objective tumor progression or death
Scoring of quality of life: EORTC-QLQ-30
Quality of life was evaluated using EORTC-QLQ-30. All subscales are summed to compute a total score, and total scores are recorded. Lower scores represent a better outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03639168
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
June 24, 2020 (Actual)
Study Completion Date
June 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenoid Cystic Carcinomas, Cisplatin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chidamide combined with Cisplatin
Arm Type
Experimental
Arm 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
Intervention Type
Drug
Intervention Name(s)
Chidamide combined with cisplatin
Intervention Description
Chidamide combined with cisplatin
Primary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
Defined as numbers of patients achieved complete response and patial response of treatment
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Disease control rate (DCR)
Description
Defined as numbers of patients achieved complete response, patial response, and stable disease of treatment
Time Frame
6 weeks
Title
Progression-free survival (PFS)
Description
Defined as the time from randomization until objective tumor progression or death
Time Frame
6 weeks
Title
Scoring of quality of life: EORTC-QLQ-30
Description
Quality of life was evaluated using EORTC-QLQ-30. All subscales are summed to compute a total score, and total scores are recorded. Lower scores represent a better outcome.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Serum ctDNA biomarker
Description
relationship between biomarker and treatment outcome
Time Frame
throughout the treatment period，up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age range 18-75 years old
Histological confirmed recurrent or metastatic head and neck adenoid cystic carcinoma
Unable to treat with surgery/radiotherapy, or previously failure to non-cisplatin systematic treatment;
Eastern Cooperative Oncology Group performance status 0 to 2;
Patients have written informed consent to participate in the study;
anticipated to live ≧3 months;
Absolute neutrophil count ≥ 1.5×109/L，platelet ≥ 100×109/L，hemoglobin ≥ 90 g/L
total bilirubin < 1.5×upper limit of normal(ULN), ALT and AST < 3× ULN
serum creatine <1.5×ULN, and creatinine clearance rate (CCR) ≥ 50 ml/min
Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed no signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
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:
Previously treated with HDACi;
Treated with cisplatin-contained regimes in the past half of the year, and not achieving PR/CR;
History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix;
HIV, HCV, or syphilis infection；
Pregnant or lactating women;
Serious uncontrolled infection;
Severe neurol of mental illness, including dementia and epilepsy;
Having contraindications to the use of oral medication, such as unable to swallow, nausea and vomiting, chronic diarrhea or suffering from a bowel obstruction;
Participated in other clinical trials in 4 weeks;
Other coexisting diseases or situations that may cause patients to fail to complete clinical trials;
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Xue, MD
Organizational Affiliation
Department of medical oncology,Fudan University, Shanghai Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kai Xue
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Chidamide Combined With Cisplatin in Head and Neck Adenoid Cystic Carcinoma (HNACC)
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