concurrent chemoradiotherapy with famitinib for patients with locally advanced nasopharyngeal carcinoma

Conditions: Locally Advanced Nasopharyngeal Carcinoma

Summary: rationale: famitinib is a tyrosin-inhibitor agent targeting at c-kit, vegfr2, pdgfr, vegfr3, flt1 and flt3. phase i study of mono famitinib has shown that the drug's toxicity is manageable. purpose: this phase i trial is studying the safety and tolerance of concurrent chemoradiotherapy with famitinib for patients with locally advanced nasopharyngeal carcinoma.


Eligibility criteria:
inclusion criteria: * histologically confirmed nasopharyngeal differentiation or undifferentiation carcinoma, who ii or iii * newly diagnosed t3-4n1（exception metastatic uni or bil retropharyngeal lymph nodes n1） or any tn2-3(7th uicc/ajcc) locally advanced nasopharyngeal carcinoma * 18-65 years of age * ecog performance status of 0 or 1 * life expectancy of more than 6 months * at least one measurable lesion :mri scan larger than 10 mm in diameter, malignant lymph nodes larger than 10 mm in short axis * female: all subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. child bearing potential, a negative urine or serum pregnancy test result before initiating famitinib. male: all subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. * signed and dated informed consent. willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure. exclusion criteria: * before or at the same time any second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * any factors that influence the usage of oral administration * known spinal cord compression or diseases of brain or pia mater by ct /mri screening * imageology shows that tumor lesion less than 5 mm to great vessels(internal carotid and jugular vein) * hemoglobin \ 1x uln, creatinine clearance rate \ 7.75 mmol/l and triglyceride \> 3 mmol/l, lvef: \< lln * hypertensive( more than 140/90 mmhg ), more than class i (nci ctcae 3.0 ) myocardial ischemia, arrhythmia(including qtcf:male ≥ 450 ms, female ≥470 ms), or cardiac insufficiency * urt: urine protein ≥ ++ and \> 1.0 g of 24 h * long-term untreated wounds or fractures * pt, aptt, tt, fbg abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation * before the first treatment occurs artery / venous thromboembolic events, such as cerebral vascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, etc * preexisting thyroid dysfunction, even using medical therapy, thyroid function cannot maintain in the normal range * abuse of psychiatric drugs or dysphrenia * subject of viral hepatitis type b or type c * subject of immunodeficiency: hiv positive, or other acquired immunodeficiency, congenital immunodeficiency, or organ transplantation * with drug cyp3a4 inhibitor, inducer, or substrate * evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study

Keywords: concurrent chemoradiotherapy