Clinical trial NCT02883374: Chidamide for Advanced Cephalic and Cervical Adenocystic Carcinoma: Evaluation of Efficiency and Safety
Official title: Chidamide for Advanced Cephalic and Cervical Adenocystic Carcinoma: Evaluation of Efficiency and Safety
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Adenocystic Carcinoma
Keywords: cephalic and cervical adenocystic Carcinoma
Chidamide
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to evaluate the efficiency and safety of Chidamide in advanced cephalic and cervical adenoid cystic carcinoma. Chidamide is given to patients with advanced cephalic and cervical adenoid cystic carcinoma with the dosage of 30mg,twice a week, then overall survival, event-free survival are accessed for efficiency, and laboratory tests about the function of vital organs are accessed for safety.


Eligibility criteria: Inclusion Criteria:

1. Patients of advanced cephalic and cervical adenocystic carcinoma with pathological and imaging evidences, with local relapse or metastasis or refractory towards treatment.
2. Age 18-75, male or female, expected survival≥ 3 months.
3. ECOG 0-2.
4. With at least one evaluable disease focus.
5. Organ functions should fit the following:

Liver: Total bilirubin ≤ 1.5 times of the normal maximum, ALT and AST≤ 2.5 times of the normal maximum. (ALT/AST≤ 5 times of the normal maximum for patients with infiltrative liver disease) Kidney: Serum creatinine ˂ 1.5 folds of the normal maximum; creatinine clearance rate ≥50ml/min (calculated by Cockroft-Gault10 formula)

Exclusion Criteria:

1. History of HDACI treatment.
2. Women during pregnancy or lactation.
3. Patients with a second primary tumor ( this does not include non-melanoma skin cancer received systemic treatment, cured cervical carcinoma in situ of the uterus, or other tumors that have been cured with disease free survival˃ 5 years)
4. Patients with central nervous system defects or mental disorders.
5. Other diseases or contraindications: History of heart disease within 6 months prior to inclusion, including NYHA III-IV heart failure after treatment, coronary heart disease, angina pectoris, myocardial infarction, degree II or III atrioventricular block, severe arrhythmias that need medical treatment, uncontrolled hypertension; liver cirrhosis (Child-Pugh B or C); active infection that has not been controlled, and other conditions that may make the patient unable to complete the trial.

Primary outcomes:
measure: Disease control rate
timeFrame: through study completion, an average of 33 months
Secondary outcomes:
measure: Toxicities
timeFrame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months
measure: QOL score
timeFrame: every 3 weeks though study completion，from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 33 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Science
state: Beijing
Study officials:
affiliation: Cancer Hospital, Chinese ACademy of Medical Science
name: Mei Dong, Doctor
role: PRINCIPAL_INVESTIGATOR
References: