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Stage IV Nasopharyngeal CarcinomaPhase 2NCT01616849

Study of Chemotherapy Combined With Nimotuzumab in Untreated Metastatic Nasopharyngeal Carcinoma

A Phase 2 study testing cisplatin and 5-Fu combined with nimotuzumab in people with Stage IV Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Stage IV Nasopharyngeal Carcinoma
What is being tested?
cisplatin and 5-Fu combined with nimotuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteChina
Study dates
May 2012to Jul 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Center, Sun Yat-sen University

    Guangzhou, Guangdong

Other trials in China

About this study

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

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.

Being tested
cisplatin and 5-Fu combined with nimotuzumab
Medical subject headings
Nasopharyngeal Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT01616849
Study groupRoleWhat they receive
PF+ NimotuzumabExperimentalPatients treated with cisplatin and 5-Fu combined with nimotuzumab
Receives: Drug: cisplatin and 5-Fu combined with nimotuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate

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

    Measured: study period of 19 Months

  2. 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.

    Measured: 19 Months

Secondary outcomes (2)

  1. Overall survival

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

    Measured: 19 Months

  2. Quality of life

    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.

    Measured: 8 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionJul 2015
  4. Study completionJul 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01616849
Sponsor's protocol ID
PF-N-UMNPC
Status last verified
Sep 2015
First submitted
20 May 2012
Last updated
22 Sep 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30689735

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cisplatin and 5-Fu combined with nimotuzumab in people with Stage IV Nasopharyngeal Carcinoma, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (time frame: study period of 19 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01616849, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015.

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