A Study of Apatinib Plus Tegafur Gimeracil Oteracil in Recurrent/Metastatic Head and Neck Cancers

A Non-randomized Phase II Study of Apatinib Mesylate Tablets Plus Tegafur Gimeracil Oteracil Potassium Capsules in Recurrent/Metastatic Squamous Cell Carcinoma of Head and Neck

This is a non-randomized, phase II, open label study of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium capsules in recurrent/metastatic squamous cell carcinoma of head and neck. The primary purpose of this study is to evaluate the efficacy of apatinib mesylate tablets plus tegafur gimeracil oteracil potassium capsules in recurrent/metastatic squamous cell carcinoma of head and neck

Study Overview

• Status: Unknown
• Conditions: Head and Neck Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Apatinib Mesylate Tablets; Drug: Tegafur Gimeracil Oteracil Potassium Capsules

• Study Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200011
      • Shanghai Ninth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Histologically / cytologically confirmed diagnosis of recurrent or metastatic squamous cell carcinoma of head and neck origin not amenable to curative intent therapy; both human papillomavirus (HPV)(+) and HPV(-) tumors are eligible; tumors (squamous histology) of unknown primary that are clearly related to the head and neck area are eligible
2. Presence of measurable lesions (RECIST V1.1)
3. Eastern Cooperative Oncology Group (ECOG) performance status =< 2

4. Absolute neutrophil count (ANC) >= 1.5 x 10^9/L

   • Platelets >= 100 x 10^9/L
   • Hemoglobin (Hb) > 9 g/dL
   • Total calcium (corrected for serum albumin) within normal limits
   • Magnesium >= the lower limit of normal for the institution
   • Potassium within normal limits for the institution
   • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) within 1.5 x normal range (or =< 3.0 x upper limit of normal [ULN] if liver metastases are present)
   • Serum bilirubin within normal range (or =< 1.5 x ULN if liver metastases are present; or total bilirubin =< 3.0 x ULN with direct bilirubin within normal range in patients with well documented Gilbert syndrome)
   • Serum creatinine =< 1.5 x ULN or 24-hour clearance >= 50 mL/min
   • Serum amylase =< ULN
   • Serum lipase =< ULN
   • Fasting plasma glucose =< 120 mg/dL (6.7 mmol/L)
5. Negative serum pregnancy test within 72 hours before starting study treatment in women with childbearing potential
6. Signed informed consent

Exclusion Criteria:

1. Patients with poor-controlled arterial hypertension (systolic pressure ≥ 140 mmHg and/or diastolic pressure ≥ 90 mm Hg) despite standard medical management;
2. 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%;
3. Patients who have had prior allergic reaction to Apatinib;
4. The subject has had another active malignancy within the past five years except for cervical cancer in site, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin;
5. Clinically significant and uncontrolled major medical conditions including but not limited to: active uncontrolled infection, symptomatic congestive heart failure, Unstable angina pectoris or cardiac arrhythmia, psychiatric illness/ social situation that would limit compliance with study requirements; any medical condition, which in the opinion of the study investigator places the subject at an unacceptably high risk for toxicities;
6. Patients undergoing therapy with other investigational agents.
7. Women who are pregnant or breastfeeding;
8. Patients with any other concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for participation in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Group; Apatinib Mesylate Tablets and Tegafur Gimeracil Oteracil Potassium Capsules administered as a daily oral treatment	Drug: Apatinib Mesylate Tablets; 500 mg qd.p.o. every day for 21 days as a cycle; Other Names: Aitan; Drug: Tegafur Gimeracil Oteracil Potassium Capsules; 50mg bid p.o. every day for 14 days as a cycle; Other Names: Aiyi

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival(PFS)	from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years	2 years
Overall survival	from date of enrollment until date of first death from any cause, assessed up to 2 years	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute toxicity profiles, graded according to the NCI CTCAE version 3.0	Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v3.0 during the course of treatment	6 months

Collaborators and Investigators

• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2016
• Primary Completion (Actual): July 31, 2018
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: March 25, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): March 30, 2017

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 7, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Apatinib; head and neck cancer; Tegafur Gimeracil Oteracil
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib; Tegafur
• Other Study ID Numbers: 2017HNRT001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No