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

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Nasopharyngeal Carcinoma
• Intervention / Treatment: Drug: Docetaxel and Cisplatin and Nimotuzumab

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangzhou, China, 51000
    • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Docetaxel and Cisplatin and Nimotuzumab; 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.	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) ;

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
disease control rate	the proportion of patients achieved CR, PR, or stable disease [SD]	up to 18 weeks
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
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
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
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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2018
• Primary Completion (Actual): July 20, 2022
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: October 14, 2018
• First Submitted That Met QC Criteria: October 14, 2018
• First Posted (Actual): October 17, 2018

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Neoplasms; Carcinoma; Nasopharyngeal Carcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Docetaxel; Nimotuzumab
• Other Study ID Numbers: B2018-097-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No