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Squamous Cell Carcinoma of the Head and NeckPhase 3CHANGENCT01177956

A Trial to Determine the Safety and Anti-tumor Activity Profile of the Combination of Cetuximab and Concomitant Cisplatin Plus 5-Fluorouracil (5-FU) in Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma in Head and Neck

A Phase 3 study testing Cetuximab, Cisplatin and 5-Fluorouracil in people with Squamous Cell Carcinoma of the Head and Neck, run by Merck KGaA, Darmstadt, Germany at 14 sites in 2 countries.

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

The primary objective of this trial is to assess the antitumor activity and safety profile of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of recurrent and/or metastatic Squamous Cell Carcinoma in Head and Neck (SCCHN) in Asian subjects. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cetuximab, Cisplatin and 5-Fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
14 sitesin 2 countries
Study dates
Dec 2009to Nov 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent
  • Inpatient
  • Greater than or equal to (>=) 18 years of age
  • Histologically or cytologically confirmed diagnosis of SCCHN
  • Recurrent and/or metastatic SCCHN not suitable for local therapy
  • Presence of at least 1 measurable lesion identified either by computed tomography (CT) scan or magnetic resonance imaging (MRI) according to modified WHO criteria
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  • Karnofsky performance status (KPS) >= 80 percent at trial entry
  • Neutrophils >= 1.5*10^9 per liter (L), platelet count >= 100*10^9 per L, and hemoglobin >= 90 gram per liter (g/L)
  • Total bilirubin less than or equal to (<=) 2*upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <=3*ULN
  • Serum creatinine <=133 micromole per liter (mcmol/L)
  • Serum calcium within normal range
  • Effective contraception if procreative potential exists (applicable for both male and female subjects)

Who cannot join

  • Prior systemic chemotherapy, except if given as part of a multimodal treatment which was completed more than 6 months prior to trial entry
  • Surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before trial entry
  • Nasopharyngeal carcinoma
  • Active infection (infection requiring IV antibiotics), including active tuberculosis, or known and declared human immunodeficiency virus (HIV)
  • Uncontrolled diabetes mellitus, pulmonary fibrosis, acute pulmonary disorder, interstitial pneumonia, cardiac failure or liver failure
  • Uncontrolled hypertension defined as systolic blood pressure >=180 millimeter of mercury (mmHg) and/or diastolic blood pressure >=130 mmHg under resting conditions
Show all 21Show fewer
  • Pregnancy (absence to be confirmed by serum beta human chorionic gonadotrophin [beta-HCG] test) or breastfeeding
  • Concomitant chronic systemic immune therapy or hormonal therapy as cancer therapy
  • Other concomitant anticancer therapies
  • Documented or symptomatic brain or leptomeningeal metastasis
  • Clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency
  • Medical or psychological condition that would not permit the subject to complete the trial or sign informed consent
  • Known drug abuse (with the exception of alcohol abuse)
  • Known hypersensitivity or allergic reaction against any of the components of the trial treatment
  • Previous treatment with monoclonal antibody therapy, other signal transduction inhibitors or epidermal growth factor receptor (EGFR) targeting therapy
  • Previous or current other squamous cell carcinoma (SCC)
  • Evidence of previous other malignancy within the last 5 years
  • Signs and symptoms suggestive of transmissible spongiform encephalopathy, or family members who suffer(ed) from such
  • Intake of any investigational medication within 30 days before trial entry
  • Legal incapacity or limited legal capacity
  • Other significant disease that in the Investigator's opinion would exclude the subject from the trial

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

China13 sites

  • Cancer Institute & Hospital, Chinese Academy of Medical Sciences

    Beijing

  • Jilin Cancer Hospital

    Changchun

  • The Xiangya 2nd Hospital of Central South University

    Changsha

  • Fuijan Provincial Tumor Hospital

    Fuijian

  • Nanfang Hospital of Nanfang Medical University

    Guangzhou

  • Sun Yat-Sen Univesity Cancer Center

    Guangzhou

  • Zhejiang Provincial Tumor Hospital

    Hangzhou

  • Jiangsu Cancer Hospital

    Jiangsu, Nanjing

  • Tumor Hospital of Guangxi Zhuang Autonomous Region / The Tumor Affiliated Hospital of Guangxi Medical University

    Nanning

  • Eye & ENT Hospital of Fundan University

    Shanghai

  • Fundan University Shanghai Cancer Center

    Shanghai

  • Tongji Hospital of Tongji Medical College of Huazhong University of Science & Technology

    Wuhan

  • Xijing Hospital, the Fourth Military Medical University

    Xi'an

Other trials in China

South Korea1 site

  • Clinical Trial Center of Medical Research Institute, Pusan National University Hospital

    Busan

Other trials in South Korea

About this study

Official title: Open-label, Single-arm, Multicenter, Phase III Trial to Assess the Antitumor Activity and Safety Profile of Cetuximab When Given in Combination With Chemotherapy for the First-line Treatment of Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck in Asian Subjects

The primary objective of this trial is to assess the antitumor activity and safety profile of cetuximab when given in combination with cisplatin + 5-Fluorouracil (5-FU) for the first-line treatment of recurrent and/or metastatic Squamous Cell Carcinoma in Head and Neck (SCCHN) in Asian subjects.

Keywords
Recurrent and/or metastatic squamous cell carcinoma of the head and neck, 1st-line, Cetuximab, Chemotherapy, EMR 62241 -055, Merck KGaA, Recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN)
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.

  • CetuximabBiological

    Also called Erbitux®

    The initial dose of cetuximab will be 400 milligram per square meter (mg/m^2) as an intravenous (IV) infusion over 120 minutes. Subsequent weekly doses will be 250 mg/m^2 as an IV infusion over 60 minutes.

    Chemotherapy will be continued for up to a maximum of six 3-week cycles in the absence of progressive disease (PD) or unacceptable toxicity. All subjects will receive cetuximab treatment until the occurrence of PD or unacceptable toxicity to cetuximab.

  • CisplatinDrug

    Subjects will receive 75 mg/m^2 cisplatin as an IV infusion over 60 minutes on day 1 of each 3-week treatment cycle.

  • 5-FluorouracilDrug

    Subjects will receive 750 mg/m^2 per day 5-FU as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle.

Study groups in NCT01177956
Study groupRoleWhat they receive
Cetuximab + Cisplatin + 5-Fluorouracil (5-FU)ExperimentalNot described
Receives: Biological: Cetuximab; Drug: Cisplatin; Drug: 5-Fluorouracil

What is being measured

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

  1. Best Overall Response (BOR) Until Cut-off Date 25 January 2011

    BOR: Percentage of participants experiencing a Complete Response (CR) (complete disappearance of measurable and evaluable disease without new lesions) or Partial Response (PR) (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified World Health Organization [WHO] criteria), divided by the number of participants belonging to intention to treat (ITT) or safety population.

    Measured: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011

  2. Best Overall Response (BOR) Until Cut-off Date 15 November 2012

    BOR: Percentage of participants experiencing a CR (complete disappearance of measurable and evaluable disease without new lesions) or PR (greater than or equal to 50 percent decrease of sum of product diameters of measurable disease, evaluable disease not worsening or progressing, no new lesions confirmed by a subsequent assessment no less than 28 days after criteria for response were first met) (based on modified WHO criteria), divided by the number of participants belonging to ITT or safety population.

    Measured: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012

Secondary outcomes (7)

  1. Overall Survival (OS) Time Until Cut-off Date 15 November 2012

    The OS time was defined as the time from first administration of trial treatment to death. Participants without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.

    Measured: Time from randomization to death or last day known to be alive, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012

  2. Progression-free Survival (PFS) Time Until Cut-off Date 25 January 2011

    Duration from first administration of trial treatment until progression (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.

    Measured: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011

  3. Progression-free Survival (PFS) Time Until Cut-off Date 15 November 2012

    Duration from first administration of trial treatment until progression (radiological or clinical, if radiological progression is not available) or death due to any cause. Only deaths within 60 days of last tumor assessment are considered. Participants without event are censored on the date of last tumor assessment.

    Measured: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012

  4. Time to Progression (TTP) Until Cut-off Date 25 January 2011

    Time from first administration of trial treatment to disease progression (radiological or clinical, if radiological progression is not available). Participants without event are censored on the date of last tumor assessment.

    Measured: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011

  5. Time to Progression (TTP) Until Cut-off Date 15 November 2012

    Time from first administration of trial treatment to disease progression (radiological or clinical, if radiological progression is not available). Participants without event are censored on the date of last tumor assessment.

    Measured: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012

  6. Duration of Response Until Cut-off Date 25 January 2011

    Time from first assessment of CR or PR to disease progression or death (within 60 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.

    Measured: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011

  7. Duration of Response Until Cut-off Date 15 November 2012

    Time from first assessment of CR or PR to disease progression or death (within 60 days of last tumor assessment). Participants without event are censored on the date of last tumor assessment. Tumor assessments based on modified WHO criteria.

    Measured: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 15 November 2012

Timeline

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

  1. First posted9 Aug 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionJan 2011
  4. Study completionNov 2012

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01177956
Sponsor's protocol ID
EMR62241_055
Acronym
CHANGE
Status last verified
Aug 2014
First submitted
2 Jun 2010
Last updated
3 Sep 2014
Data monitoring committee
Yes

Publications

  • Guo Y, Shi M, Yang A, Feng J, Zhu X, Choi YJ, Hu G, Pan J, Hu C, Luo R, Zhang Y, Zhou L, Cheng Y, Lupfert C, Cai J, Shi Y. Platinum-based chemotherapy plus cetuximab first-line for Asian patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck: Results of an open-label, single-arm, multicenter trial. Head Neck. 2015 Aug;37(8):1081-7. doi: 10.1002/hed.23707. Epub 2014 Sep 17.

    PubMed 24710768

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cetuximab, Cisplatin and 5-Fluorouracil in people with Squamous Cell Carcinoma of the Head and Neck, run by Merck KGaA, Darmstadt, Germany at 14 sites in 2 countries.

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 12 inclusion and 21 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 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in China, South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Best Overall Response (BOR) Until Cut-off Date 25 January 2011 (time frame: Evaluations were performed every 6 weeks until progression, reported between day of first participant randomized, 25 December 2009, until cut-off date 25 January 2011). 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 NCT01177956, 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 3 Sep 2014.

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