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This study is a phase II clinical study. Recurrence after radiotherapy patients who are failure of radiotherapy in recurrent or metastatic nasopharyngeal carcinoma (NPC) were treated by cisplatin and 5-fluorouracil with Sorafenib as first-line treatment. The objective response(complete response (CR) + partial response (PR)), Disease Control Rate , safety profile, tolerability will be evaluated according to World Health Organization (WHO) criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Sorafenib with Cisplatin and 5-fluorouracil as first-line treatment of recurrence after radiotherapy patients who failed with radiotherapy in recurrent or metastatic nasopharyngeal carcinoma (NPC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sorafenib plus Cisplatin and 5-fluorouracil | Drug | Sorafenib with Cisplatin and 5-fluorouracil as first-line treatment of recurrence after radiotherapy patients who failed with radiotherapy in recurrent or metastatic nasopharyngeal carcinoma (NPC)
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (CR+PR) | In the ITT analysis(n=54), the ORR reached 77.8%: one patient (1.9%) experienced CR; 41 (75.9%), PR. | January 2009 to May 2011 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease control rate | The disease control rate (DCR) was 90.8%. | January 2009 to May 2011 |
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Inclusion Criteria:
Age > 18 years
ECOG Performance Status of 0 or 1
Life expectancy of at least 12 weeks
Pathologically confirmed nasopharyngeal carcinoma
Experience of treatment failure with radiotherapy for recurrent or metastatic NPC
More than 3 weeks must have elapsed since previous radiotherapy
Biomarkers measuring including pERK, EGFR of original diagnostic paraffin-embedded tumor samples; VEGF of pre-dose and post-dose plasma samples.
Subjects with at least one (for RECIST) measurable lesion (Tumor lesions that are situated in a previously irradiated area could not be considered measurable)
Adequate bone marrow, liver and renal functions as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
Signed and dated informed consent before the start of specific protocol procedures
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, MD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Center of Sun-Yat Sen University | Guangzhou | Guangdong | 510000 | China |
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|
| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077157 | Sorafenib |
| D002945 | Cisplatin |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
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