Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma

• Sponsor: Sun Yat-sen University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01616849
• Collaborator: Fujian Cancer Hospital (Other), First People's Hospital of Foshan (Other), People's Hospital of Guangxi (Other), Guangxi Medical University (Other), Guangzhou Medical University (Other), Hubei Cancer Hospital (Other), Hunan Provincial Cancer Hospital (Other), Hangzhou Cancer Hospital (Other), Wuhan Union Hospital, China (Other), Tongji Hospital (Other), Jiangxi Provincial Cancer Hospital (Other), Affiliated Cancer Hospital of Shantou University Medical College (Other), Wuhan University (Other), Zhejiang Cancer Hospital (Other)
• Enrollment: 39
• Location: 1
• Arm: 1
• Duration (Months): 38
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

This is an open-label, uncontrolled, multicenter phase II clinical trial. The purpose of this study is to evaluate acute toxicity and efficacy of cisplatin and 5-Fu combined with nimotuzumab in patients with untreated metastatic nasopharyngeal carcinoma.

Condition or Disease	Intervention/Treatment	Phase
Stage IV Nasopharyngeal Carcinoma	Drug: cisplatin and 5-Fu combined with nimotuzumab	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Open-Label, Uncontrolled, Multicenter Phase II Study of Cisplatin and 5-Fu Combined With Nimotuzumab As First-Line Treatment in Patients With Untreated Metastatic Nasopharyngeal Carcinoma
• Study Start Date: May 1, 2012
• Actual Primary Completion Date: Jul 1, 2015
• Actual Study Completion Date: Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF+ Nimotuzumab Patients treated with cisplatin and 5-Fu combined with nimotuzumab	Drug: cisplatin and 5-Fu combined with nimotuzumab; DDP+5-Fu DDP 100 mg/m2 intravenous infusion in day1, 5-Fu 1000mg/m2/d continuous intravenous infusion on days 1 through 4, both drugs are given every 3 weeks. Nimotuzumab 200mg/d, intravenous infusion every week

Outcome Measures

Primary Outcome Measures

1. Objective response rate [study period of 19 Months]

   To be determined by measurement of target lesions according to RECIST criteria

2. Progression free survival [19 Months]

   Defined as the time in months from first dose of Nimotuzumab until PD is observed or death occurs due to any cause.

Secondary Outcome Measures

1. Overall survival [19 Months]

   Defined as the time in months from first dose of Nimotuzumab to the date of death is observed or to last follow-up visit.

2. Quality of life [8 Months]

   Using EORTC QLQ-C30(version 3.0) and EORTC QLQ-H&N35(Version 1.0) to access the quality of life. Collecting data before treatment, 1 week after each 2 cycles of chemotherapy, 1 months after all treatment finished.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Histologic diagnosis of nasopharyngeal carcinoma

• Distance metastasis at least 6 months after radical treatment

• Not suitable for local treatment, e.g. surgery, TACE

• At least one measurable lesion

• Estimate survival >3months

• Range from 18～70 years old

• PS 0~1

• WBC count ≥ 4×109/L，Hemoglobin ≥ 100g/L， platelet count ≥ 100×109/L

• ALT or AST < 2.5×ULN、bilirubin < 1.5×ULN

• 0Serum creatinine < 1.5×ULN

Exclusion Criteria:

• Central nervous system metastases

• Suitable for local treatment

• Second malignancy within 5 years

• Precious therapy with an investigational agent

• Uncontrolled seizure disorder or other serious neurologic disease

• ≥ Grade Ш allergic reaction to any drug including in this study

• Clinically significant cardiac or respiratory disease

• Creatinine clearance < 30ml/min

• Drug or alcohol addition

• Do not have full capacity for civil acts

• Severe complication, active infection

• Concurrent immunotherapy or hormone therapy for other diseases

• Pregnancy or lactation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cancer Center, Sun Yat-sen University	Guangzhou	Guangdong	China

Sponsors and Collaborators

• Sun Yat-sen University
• Fujian Cancer Hospital
• First People's Hospital of Foshan
• People's Hospital of Guangxi
• Guangxi Medical University
• Guangzhou Medical University
• Hubei Cancer Hospital
• Hunan Provincial Cancer Hospital
• Hangzhou Cancer Hospital
• Wuhan Union Hospital, China
• Tongji Hospital
• Jiangxi Provincial Cancer Hospital
• Affiliated Cancer Hospital of Shantou University Medical College
• Wuhan University
• Zhejiang Cancer Hospital

Investigators

• Principal Investigator: Chong Zhao, MD, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Home Page of Cancer Center, Sun Yat-sen University

Publications

None provided.

• Responsible Party: Zhao Chong, MD, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT01616849
• Other Study ID Numbers: PF-N-UMNPC
• First Posted: Jun 12, 2012
• Last Update Posted: Sep 22, 2015
• Last Verified: Sep 1, 2015

• Additional relevant MeSH terms: Carcinoma; Nasopharyngeal Carcinoma; Nimotuzumab

Study Results

No Results Posted as of Sep 22, 2015