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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Either at 12.5 mg, 16.5 mg、20 mg or 25 mg qd p.o., 2 weeks before concurrent chemoradiotherapy and D1-D49, exception D1, D22, and D43.
100 mg/m2, D1, D22, and D43(q3w)
IMRT (Intensity-Modulated Radiation Therapy). Radiation is delivered to GTV at 70 Gy in 32-33 fractions, CTV1 at 60 Gy in 32-33 fractions and CTV2 at 54 Gy in 32-33 fractions
Department of Medical Oncology, Cancer Center, Sun Yet-sen University
Guangzhou, Guangdong, China
Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD)
To evaluate the DLT and MTD in patients with Concurrent Chemoradiotherapy With Famitinib
Time frame: 3 weeks
ORR (Objective Response Rate)
Time frame: 12 weeks after treatment
OS(Overall Survival)
Time frame: 2 years and 3 years
DFMR(Distant Free Metastases Rate)
Time frame: 2 years and 3 years
DFSR(Disease Free Survival Rate)
Time frame: 2 years and 3 years
LFRSR(Local Free Recurrence Survival Rate)
Time frame: 2 years and 3 years
Quantitative evaluation of the blood perfusion of the metastatic cervical lymph nodes by dynamic contrast-enhanced ultrasonography after a loading dose of famitinib for 14 days
Time frame: 2 weeks
To identify the tumor's molecular profiles in patients with NPCs
Time frame: 2 years
To measure the changes of serum c-Kit,VEGF,Filt,KDR,and PDGFR
Time frame: 2 years
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