Nasopharyngeal Carcinoma
Conditions
Brief summary
The purpose of this single arm,phase Ⅱ clinical trail is to determine the safety and efficacy of docetaxel and cisplatin combined with Nimotuzumab in the treatment of recurrent and metastatic nasopharyngeal carcinoma
Interventions
DRUGDocetaxel and Cisplatin and Nimotuzumab
Intravenous nimotuzumab (200 mg on days 1, 8, and 15) ; Intravenous docetaxel (75 mg/m2 on day 1) ; Intravenous cisplatin (75 mg/m2 on day 1) ;
Sponsors
Sun Yat-sen University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* biopsy proved nasopharyngeal carcinoma; * stage IVB according to the eighth edition American Joint Committee on Cancer/Union for International Cancer Control staging system, or recurrent disease beyond more than 6 months after curative chemotherapy and/or radiotherapy; * 18-70 years; * without other malignancy; * had at least one measurable disease; * had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; * estimated life expectancy exceeding 3 months; * adequate functions of the major organs.
Exclusion criteria
* allergic to docetaxel or cisplatin or nimotuzumab; * pregnant or lactating female; * patients received other clinical trails within 3 months; * had serious infections, comorbidities or vital organs dysfunction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | up to 18 weeks | the proportion of patients achieved partial response (PR) and complete response (CR) according to RECIST v1.1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| disease control rate | up to 18 weeks | the proportion of patients achieved CR, PR, or stable disease \[SD\] |
| duration of response | From date of documented response until the date of progressive disease [PD] or death, whichever came first, assessed up to 12 months | time interval from the first day of documented response to progressive disease \[PD\] or death from any cause |
| progression-free survival | From date of the enrollment until the date of the documented PD or death, whichever came first, assessed up to 12 months | time interval from the enrolled date to the documented PD or death from any cause or censored at the last follow-up |
| overall survival | From date of the enrollment until the date of the documented death, assessed up to 72 months | time interval from the enrolled date to death from any cause or last follow-up |
| adverse events | up to 18 weeks | treatment-related adverse events graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 |
Countries
China
Outcome results
None listed