Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Open-Label, Multicenter, Phase Ⅱ Study of Docetaxel and Cisplatin Combined With Nimotuzumab As First-Line Treatment in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03708822
• Other study ID #: B2018-097-01
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: October 15, 2018
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: June 30, 2024
• Est. primary completion date: July 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• Docetaxel 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) ;

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,	Guangzhou

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall response rate	the proportion of patients achieved partial response (PR) and complete response (CR) according to RECIST v1.1	up to 18 weeks
Secondary	disease control rate	the proportion of patients achieved CR, PR, or stable disease [SD]	up to 18 weeks
Secondary	duration of response	time interval from the first day of documented response to progressive disease [PD] or death from any cause	From date of documented response until the date of progressive disease [PD] or death, whichever came first, assessed up to 12 months
Secondary	progression-free survival	time interval from the enrolled date to the documented PD or death from any cause or censored at the last follow-up	From date of the enrollment until the date of the documented PD or death, whichever came first, assessed up to 12 months
Secondary	overall survival	time interval from the enrolled date to death from any cause or last follow-up	From date of the enrollment until the date of the documented death, assessed up to 72 months
Secondary	adverse events	treatment-related adverse events graded for severity according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0	up to 18 weeks