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| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug: Famitinib | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Famitinib | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) | To evaluate the DLT and MTD in patients with Concurrent Chemoradiotherapy With Famitinib | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| ORR (Objective Response Rate) | 12 weeks after treatment | |
| OS(Overall Survival) | 2 years and 3 years | |
| DFMR(Distant Free Metastases Rate) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medical Oncology, Cancer Center, Sun Yet-sen University | Guangzhou | Guangdong | China |
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| ID | Term |
|---|---|
| C584390 | famitinib |
| D002945 | Cisplatin |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
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| Cisplatin | Drug | 100 mg/m2, D1, D22, and D43(q3w) |
|
| radiation(IMRT) | Radiation | 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 |
|
| 2 years and 3 years |
| DFSR(Disease Free Survival Rate) | 2 years and 3 years |
| LFRSR(Local Free Recurrence Survival Rate) | 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 | 2 weeks |
| To identify the tumor's molecular profiles in patients with NPCs | 2 years |
| To measure the changes of serum c-Kit,VEGF,Filt,KDR,and PDGFR | 2 years |