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

Sun Yat-sen University

Status and phase: Active, not recruiting; Phase 2

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: Docetaxel and Cisplatin and Nimotuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT03708822

B2018-097-01

Details and patient eligibility

About

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

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Docetaxel and Cisplatin and Nimotuzumab

Experimental group

Description:

All eligible patients received intravenous nimotuzumab plus docetaxel and cisplatin every 3 weeks for a maximum of 6 cycles, or until disease progression, death, intolerable toxicity.

Treatment:

Drug: Docetaxel and Cisplatin and Nimotuzumab