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Head and Neck Squamous Cell CarcinomaPhase 2NCT01425736

Nimotuzumab in Combination With TPF(Cisplatin ,Fluorouracil and Docetaxel) for Head and Neck Squamous Cell Carcinoma

A Phase 2 study testing Chemotherapy and Nimotuzumab and Chemotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Wei Guo at 5 sites 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

Nimotuzumab (hR3) is an humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). In phase II clinical trials a combination of Nimotuzumab with chemotherapy or radiation therapy achieved satisfactory therapeutic outcomes in… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Chemotherapy and Nimotuzumab and Chemotherapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
91 participants
Where
5 sitesChina
Study dates
Jan 2009to Mar 2013
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Joined the study voluntary and signed informed consent form
  • Age 18-75，both genders.
  • Had histologically or cytologically confirmed recurrent or metastatic squamous cell carcinoma of the head and neck
  • At least one lesions can be measured,Conventional measurements ≥2cm, computed tomography(CT) examination ≥1cm .
  • Eastern Cooperative Oncology Group(ECOG) Performance Scale 0-2.
  • Life expectancy of more than 3 months.
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  • Use of an effective contraceptive method for women when there is a risk of pregnancy during the study.
  • Haemoglobin≥90g/L ,White blood cell(WBC) ≥3×10^9/L
  • Hepatic function:ALAT、ASAT< 2.5 x ULN, TBIL< 1.5 x ULN
  • Renal function: Creatinine < 1.5 x ULN

Who cannot join

  • Received other anti EGFR monoclonal antibody treatment
  • Participation in other interventional clinical trials within 1 month
  • Previous received other drug or operative treatment within 6 month
  • Pregnant or breast-feeding women
  • History of serious allergic or allergy
  • Patients with the history of Serious lung or head disease
  • Other malignant tumor
  • not primary tumor(except for primary tumor therapy>3months)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

China5 sites

  • First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510000

  • Institute of Stomatology of Nanjing Medical University

    Nanjing, Jiangsu, 210000

  • 9th People's Hospital, School of Stomatology,Shanghai Jiaotong University

    Shanghai, Shanghai Municipality, 200011

  • Wuxi People's Hospital; Nanjing Medical University

    Wuxi, Jiangsu, 214000

  • Xuzhou Central Hospital of Xuzhou city,Dongnan University

    Xuzhou, Jiangsu, 221009

Other trials in China

About this study

Official title: Phase 2 Study of Nimotuzumab in Combination With TPF for Head and Neck Squamous Cell Carcinoma

Nimotuzumab (hR3) is an humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR). In phase II clinical trials a combination of Nimotuzumab with chemotherapy or radiation therapy achieved satisfactory therapeutic outcomes in patients with advanced squamous cell carcinoma of head and neck, or glioblastoma. We therefore postulated that Nimotuzumab in combination with conventional definitive chemotherapy might improve the rate of disease control (RDC), progression-free survival (PFS),and overall survival in patients with recurrent and/or metastatic SCCHN , which is a poor-prognosis patient population for whom there is currently no standard treatment approach, we designed this trial to test this hypothesis.

Read the detailed description

Eligible patients were randomly assigned by using permutated blocks designed11 for each site to receive either Nimotuzumab combined with docetaxel-cisplatin-fluorouracil regimen (Arm A) or docetaxel-cisplatin-fluorouracil alone regimen (Arm B). Combination arm chemotherapy was as conducted as follows. Since day 1, Nimotuzumab (200 mg, given as a 2-hour intravenous infusion before chemotherapy, Biotech Pharmaceutical Inc., Beijing, China) was administrated 1 h before chemotherapy once a week for two successive courses, followed by docetaxel (at a dose of 75 mg per square meter of body-surface area) was administered as a 1-hour intravenous infusion, followed by intravenous cisplatin (75 mg per square meter), administered during a period of 0.5 to 3 hours. After completion of the cisplatin infusion, fluorouracil (1000 mg per square meter per day) was administered as a continuous 24-hour infusion for 4 days. Patients in arm A received docetaxel-cisplatin-fluorouracil only.One treatment cycle comprised a period of 3 weeks (21 days). Patients received six cycles in both treatment arms, unless disease progression or unacceptable toxicity was observed. Patients in the experimental group who had at least stable disease could choose to continue maintenance Nimotuzumab every week until disease progression, intolerable toxicity, or study withdrawal.

Being tested
Chemotherapy, Nimotuzumab and Chemotherapy
Keywords
Nimotuzumab, Chemotherapy, Head and Neck Squamous Cell Carcinoma
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

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

  • ChemotherapyDrug

    Also called Docetaxel, Cisplatin, Fluorouracil

    Chemotherapy :Docetaxel(75mg/m²,1 time/21d, 6times);Cisplatin(75mg/m²,1 time/21d, 6 times);Fluorouracil(750mg/m²/d,5times/21d, 30times)

  • Nimotuzumab and ChemotherapyDrug

    Also called Docetaxel, Cisplatin, Fluorouracil, Nimotuzumab

    Nimotuzumab treatment:(200mg/w,18weeks );

    Chemotherapy treatment:(Docetaxel(75mg/m²,1 time/21d, 6times);Cisplatin(75mg/m²,1 time/21d, 6 times);Fluorouracil(750mg/m²/d,5times/21d, 30times)Nimotuzumab treatment:(200mg/w,18weeks );

Study groups in NCT01425736
Study groupRoleWhat they receive
ChemotherapyPlacebo comparatorChemotherapy :Docetaxel(75mg/m²,1 time/21d, 6times);Cisplatin(75mg/m²,1 time/21d, 6 times);Fluorouracil(750mg/m²/d,5times/21d, 30times)
Receives: Drug: Chemotherapy
Nimotuzumab and ChemotherapyExperimentalNimotuzumab treatment:(200mg/w,18weeks ); Chemotherapy treatment: Docetaxel(75mg/m²,1 time/21d, 6times，);Cisplatin(75mg/m²,1 time/21d, 6 times);Fluorouracil(750mg/m²/d,5times/21d, 30times),Nimotuzumab treatment:(200mg/w,18weeks ).
Receives: Drug: Nimotuzumab and Chemotherapy

What is being measured

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

  1. Rate of Disease Control (RDC)

    Measured: 4years

Secondary outcomes (1)

  1. toxicity, progression-free survival (PFS), and overall survival (OS).

    Measured: 4 years

Timeline

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

  1. First posted30 Aug 2011 (estimated)
  2. Study startJan 2009
  3. Primary completionJan 2011
  4. Study completionMar 2013

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01425736
Sponsor's protocol ID
BT-IST-SCCHN-008
Status last verified
Jun 2014
First submitted
19 Aug 2011
Last updated
3 Jun 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chemotherapy and Nimotuzumab and Chemotherapy in people with Head and Neck Squamous Cell Carcinoma, run by Wei Guo at 5 sites 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 8 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 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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. Some participants in this study may receive a placebo. 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?

Rate of Disease Control (RDC) (time frame: 4years). 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 NCT01425736.

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 3 Jun 2014.

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