NCT01616849

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2012

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

June 12, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

3.2 years

First QC Date

May 20, 2012

Last Update Submit

September 19, 2015

Conditions

Stage IV Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (2)

  • Objective response rate

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

    study period of 19 Months

  • Progression free survival

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

    19 Months

Secondary Outcomes (2)

  • Overall survival

    19 Months

  • Quality of life

    8 Months

Study Arms (1)

PF+ Nimotuzumab

EXPERIMENTAL

Patients treated with cisplatin and 5-Fu combined with nimotuzumab

Drug: cisplatin and 5-Fu combined with nimotuzumab

Interventions

cisplatin and 5-Fu combined with nimotuzumabDRUG

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

PF+ Nimotuzumab

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Serum creatinine \< 1.5×ULN

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Related Publications (1)

  • Zhao C, Miao J, Shen G, Li J, Shi M, Zhang N, Hu G, Chen X, Hu X, Wu S, Chen J, Shao X, Wang L, Han F, Mai H, Chua MLK, Xie C. Anti-epidermal growth factor receptor (EGFR) monoclonal antibody combined with cisplatin and 5-fluorouracil in patients with metastatic nasopharyngeal carcinoma after radical radiotherapy: a multicentre, open-label, phase II clinical trial. Ann Oncol. 2019 Apr 1;30(4):637-643. doi: 10.1093/annonc/mdz020.

    PMID: 30689735DERIVED

Related Links

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Cisplatinnimotuzumab

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Chong Zhao, MD

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 20, 2012

First Posted

June 12, 2012

Study Start

May 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations

CN(1)