The Clinical Study of Apatinib Plus S1 for Patients With Advanced Non-squamous Head and Neck Cancer

NCT02943252 | Unknown Phase 2 DMC

• 1 other identifier: CH-H&N-008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Single-center, Open-label, Single-arm, Phase Ⅱ exploratory clinical trial evaluating the efficacy and safety of Apatinib plus S1 for patients with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer.

Conditions

Head and Neck Neoplasms

Keywords

apatinib; S1; advanced head and neck cancer; non-squamous

Outcome Measures

Primary Outcomes (1)

• Response Rate

  up to 3 years

Secondary Outcomes (3)

• Progression-free survival

  up to 3 years

• Overall survival

  up to 3 years

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  up to 3 years

Other Outcomes (2)

• serum soluble VEGFR2

  baseline

• tumor phosphorylated VEGFR2 (p-VEGFR2) expressions

  baseline

Study Arms (1)

Apatinib plus S1

EXPERIMENTAL

Patients received oral apatinib 500 mg in tablet once daily. Patients also received oral S1 in capsule 40-60mg bid, days 1-14. A treatment cycle was defined as 21 days (3 weeks).

Drug: Apatinib; Drug: S1

Interventions

Apatinib DRUG

apatinib 500 mg in tablet once daily

Also known as: ApatinibMesylate tablet

Apatinib plus S1

S1 DRUG

S-1 40-60mg bid, days 1-14 , every 3 weeks

Also known as: Tegafur, Gimeracil and Oteracil Potassium Capsules

Apatinib plus S1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years to 75 years;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2;
• Life expectancy of more than 12 weeks;
• At least one measurable lesion according to RECIST 1.1 which has not received radiotherapy =\< 3 months;
• Histologically confirmed advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous head and neck cancer, including adenocarcinoma, mucoepidermoid carcinoma, acinar cell carcinoma and adenoid cystic carcinoma;
• Recurrent and or metastatic lesions which are not suitable for local treatment;
• For patients with mucoepidermoid carcinoma, acinar cell carcinoma or adenoid cystic carcinoma, metastatic disease documented as having shown progression on a scan (CT, MRI) compared to a previous scan taken at any time in the past 12 months;
• For patients with adenocarcinoma, one regimen of prior chemotherapy was received for recurrent and or metastatic diseases;
• Adequate hepatic, renal, heart, and hematologic functions: absolute neutrophil count (ANC) ≥ 1.5×109/L, platelet count (PLT) ≥ 100×109/L, hemoglobin (HB) ≥ 90 g/L, total bilirubin (TBIL) ≤ 1.5×upper limit of normal (ULN), alternate aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1×ULN, Cr clearance ≥ 50 mL/min, international normalized ratio (INR) \< 1.5 or PT \< ULN+4s or activated partial thromboplastin time (APTT) \< 1.5×ULN, proteinuria \< (++) or urinary protein ≤ 1.0 g/24 hrs;
• For women of child-bearing age, the pregnancy test results (serum or urine) within 7 days before enrolment must be negative. They will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug. For men (previous surgical sterilization accepted), will take appropriate methods for contraception during the study until the 8th week post the last administration of study drug.
• Signed informed consent.

You may not qualify if:

• Accumulation of coelomic fluid (e.g. pleural effusion, ascites fluid, cardiac effusion) requiring treatment;
• Other malignancy within the past five years other than basal cell skin cancer, or carcinoma in situ of the cervix;
• Factors affecting the oral medication (e.g. inability to swallow, chronic diarrhea and intestinal obstruction);
• Major injuries and/or surgery =\< 4 weeks prior to registration with incomplete wound healing. Patients who have received radiotherapy (except local palliative radiotherapy), chemotherapy, molecular targeted therapy =\< 3 weeks, or nitrosoureas/mitomycin chemotherapy =\< 6 weeks prior to registration;
• Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;
• Suffered from grade II or above myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QT interval male ≥ 450 ms, female ≥ 470 ms). Grade III-IV cardiac insufficiency according to New York Heart Association (NYHA) criteria or echocardiography check: left ventricular ejection fraction (LVEF)\<50%;
• History of clinically significant haemoptysis =\< 2 months (more than half of one tea spoon of fresh blood per day) prior to registration. Coagulation disfunction, hemorrhagic tendency or receiving anticoagulant therapy;
• History of clinically relevant major bleeding event (e.g. gastrointestinal hemorrhage, bleeding ulcer, occult blood ≥ (++), and vasculitis) =\< 3 months prior to randomization;
• Patients who have active brain metastases or leptomeningeal disease. Patients with treated brain metastases are eligible if they are clinically stable with regard to neurologic function, off steroids after cranial irradiation ending at least 3 weeks prior to randomization, or after surgical resection performed at least 3 weeks prior to randomization. No evidence of Grade greater than or equal to 1 central nervous system (CNS) hemorrhage based on pretreatment CT or MRI scan;
• Centrally located tumors of local invasion of major blood vessels, or distinct interstitial lung disease by the chest radiographic findings (CT or MRI);
• Treatment with other investigational drugs or other anti-cancer therapy;
• Previous therapy with other VEGFR inhibitors (other than bevacizumab);
• Treatment in another investigational trial =\< 4 weeks prior to registration;
• History of hypersensitivity to apatinib and/or the excipients of the trial drugs;
• Active or chronic hepatitis C and/or B infection, or other active uncontrolled infection;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)

Beijing, Beijing Municipality, 100021, China

RECRUITING

Related Publications (3)

• Li J, Qin S, Xu J, Xiong J, Wu C, Bai Y, Liu W, Tong J, Liu Y, Xu R, Wang Z, Wang Q, Ouyang X, Yang Y, Ba Y, Liang J, Lin X, Luo D, Zheng R, Wang X, Sun G, Wang L, Zheng L, Guo H, Wu J, Xu N, Yang J, Zhang H, Cheng Y, Wang N, Chen L, Fan Z, Sun P, Yu H. Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Apatinib in Patients With Chemotherapy-Refractory Advanced or Metastatic Adenocarcinoma of the Stomach or Gastroesophageal Junction. J Clin Oncol. 2016 May 1;34(13):1448-54. doi: 10.1200/JCO.2015.63.5995. Epub 2016 Feb 16.

  PMID: 26884585 RESULT

• Le Tourneau C, Razak AR, Levy C, Calugaru V, Galatoire O, Dendale R, Desjardins L, Gan HK. Role of chemotherapy and molecularly targeted agents in the treatment of adenoid cystic carcinoma of the lacrimal gland. Br J Ophthalmol. 2011 Nov;95(11):1483-9. doi: 10.1136/bjo.2010.192351. Epub 2010 Dec 22.

  PMID: 21183517 RESULT

• Yamashita T, Shinden S, Watabe T, Shiotani A. Outpatient chemotherapy with S-1 for recurrent head and neck cancer. Anticancer Res. 2009 Feb;29(2):577-81.

  PMID: 19331206 RESULT

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

apatinib; S 1 (combination); Tegafur; gimeracil; potassium oxonate

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Xiaohui He, B.D.

  Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaohui He, B.D.

CONTACT

+86-13810670129; xiaohuih2008@163.com

Lin Gui, M.D.

CONTACT

+86-13520372817; guilindoctor@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 24, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2021
• Last Updated: October 24, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)