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Squamous Cell Carcinoma of the Head and NeckPhase 2CETMETNCT01830556

Randomised Phase II, Cetuximab in Combination With 5FU and Cisplatin or Carboplatin Versus Cetuximab in Combination With Paclitaxel and Carboplatin for Treatment of Patients With Metastatic Squamous Cell Carcinoma of the Head and Neck

A Phase 2 study testing Cetuximab in people with Squamous Cell Carcinoma of the Head and Neck, run by Karolinska University Hospital at 5 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Primary To investigate in patients with relapsed or metastatic squamous cell carcinoma of the head and neck whether progression free survival (PFS) in the arm with cetuximab, paclitaxel and carboplatin based chemotherapy is not markedly worse than PFS in the arm with cetuximab and 5-FU, cisplatin or carboplatin based… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
5 sitesin 2 countries
Study dates
Nov 2011to Nov 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • >18 years
  • Histologically or cytologically confirmed SCCHN, relapsed and/or metastatic
  • Patient must have a life expectancy of at least 3 months allowing adequate follow-up toxicity evaluation.
  • Clinical examination
  • 1 unidimensional lesion according to RECIST 1.1.
  • PS WHO 0-1 at study entry
Show all 10Show fewer
  • Adequate hematological function defined as WBC ≥3 x 109/litre and platelets ≥100 x 109/litre, ANC > 1.5 x 109/litre and Hb > 100 g/L
  • Adequate liver function; bilirubin < 1.5 x UNL, ALAT or ASAT<3.0 UNL, alkaline phosphates < 2.5 UNL.
  • Creatinine clearance > 50mL/min
  • Written informed consent must be obtained according to the local Ethics committee.

Who cannot join

  • > 75 years
  • Nasopharyngeal cancer and cancer of the paranasal sinuses
  • Inability to follow the treatment and evaluation schedule
  • Any other condition or therapy which in the investigator's opinion may pose a risk to the patient or interfere with the study objectives
  • Pregnant or nursing females or male or female of child-bearing potential not using adequate methods of birth-control
  • Patients with active infections or any other serious underlying medical condition, which would impair the ability of the patients to receive the protocol treatment
Show all 12Show fewer
  • Known hypersensitivity to any of the components of the treatment
  • Legal incapacity
  • Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
  • Patients with clinically relevant neuropathy
  • Previously treated for relapsed or metastatic SCCHN except radiotherapy for previously treated relapse if terminated > 3 months before start of treatment.
  • Previously treated with cetuximab, cisplatin/carboplatin, 5-FU or taxanes for locally advanced SCCHN within 3 months before study entry.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Sweden4 sites, 4 recruiting

  • Hedda Haugen

    Gothenburg, 413 45

    Hedda Haugen, MD, hedda.haugen@vgregion.se

    Hedda Haugen, MD

    Recruiting

  • Karolinska Universityhospital

    Stockholm, Stockholm County, 17176

    Teresa herlestam-calero-moreno, MD, maria.herlestam-calero-moreno@karolinska.se

    Teresa maria.herlestam-calero-moreno, MD

    Recruiting

  • Karin Söderström

    Umeå, 90189

    Karin Söderström, D, karin.soderstrom@onkologi.umu.se

    Karin Söderström, MD

    Recruiting

  • Akademiska Universityhospital

    Uppsala, 751 85

    Silvia Johansson, MD, silvia.johansson@onkologi.uu.se

    Silvia Johansson, MD

    Not yet recruiting

Other trials in Sweden

Denmark1 site, 1 recruiting

  • Lena Specht

    Copenhagen, 2100

    Lena Specht, MD DMSc Professor, lena.specht@rh.regionh.dk

    Lena Specht, MD DMSc Professor

    Recruiting

Other trials in Denmark

About this study

Official title: Cetuximab 5-FU and Cisplatin or Carboplatin Versus Cetuximab With Paclitaxel and Carboplatin Treatment of Metastatic Squamous Cell Carcinoma of Head and Neck

Primary To investigate in patients with relapsed or metastatic squamous cell carcinoma of the head and neck whether progression free survival (PFS) in the arm with cetuximab, paclitaxel and carboplatin based chemotherapy is not markedly worse than PFS in the arm with cetuximab and 5-FU, cisplatin or carboplatin based chemotherapy.

Secondary

To compare in patients with relapsed or metastatic squamous cell carcinoma of the head and neck the following study variables between both treatment arms:

  • Best overall response
  • Duration of response
  • Time to treatment failure
  • Overall survival
  • Safety
Read the detailed description

Recurrent and/or metastatic SCCHN patients are, by definition patients with recurrent disease and/or with newly diagnosed distant metastases, although this group of patients has a very heterogeneous disease characteristic, they share a dismal prognosis that has changed little in the past 30 years. The median survival time remains around 6-8 months with a poor quality of life. Patients with resectable locoregionally recurrent SCCHN may benefit from surgery. Patients with recurrent SCCHN who are not suitable for curative salvage surgery or re-irradiation, and patients who have distant metastases, usually receive CT (Cohen EE et al.) A number of compounds demonstrate single-agent activity in recurrent and/or metastatic disease including cisplatin, carboplatin, methotrexate, 5-FU, bleomycin and the taxanes ( Scantz SP et al). Cisplatin is one of the most active agents identified for head and neck cancer, with carboplatin providing an alternative for patients unable to tolerate cisplatin. While carboplatin is associated with lower response rates than cisplatin, there appears to be no difference between the agents in terms of survival

Cetuximab is a targeted therapeutic agent, a chimeric IgG1 monoclonal antibody that specifically binds to the EGFR with high affinity, internalising the receptor and preventing the ligands EGF and TGF-alfa from interacting with the receptors and thus effectively blocking ligand-induced EGFR phosphorylation. In addition, cetuximab has been found to potentiate the effects of chemotherapy and radiotherapy in experimental systems. The dose of cetuximab has been found to be generally safe and effective in several studies in major tumor types expressing the EGFR. These included colorectal cancer, squamous cell carcinoma of the head and neck and non-small cell lung cancer, with cetuximab given either in combination studies with chemotherapy and radiotherapy or as monotherapy. The main side effects of cetuximab monotherapy are hypersensitivity- and acne-like skin reactions.

Being tested
Cetuximab
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.

  • CetuximabDrug

    Also called Erbitux

    Group A:Day 1 Cetuximab 400 mg/m2 iv 120 minutes Day 8 and 15 Cetuximab 250 mg/m2 iv 60 minutes Day 1 Cisplatin 100mg/m2 or Carboplatin AUC 5 day 1-4 5-Fluorouracil 1000 mg/m2 iv 24 h Group B day 1 Cetuximab 400 mg/m2 iv 120 minutes Day 8 and 15 Cetuximab 250 mg/m2 iv 60 minutes day 1 Paclitaxel 175 mg/m2 day 1 Carboplatin AUC 5 treatment for 6 cycles thereafter day 1 Cetuximab 500 mg/m2 every second week treatment until progress or unacceptable toxicity

Study groups in NCT01830556
Study groupRoleWhat they receive
Arm A: cetuximab with 5FU and carboplatin or cisplatinActive comparatorArm A:Day 1 Cetuximab 400 mg/m2 iv 120 minutes Day 8 and 15 Cetuximab 250 mg/m2 iv 60 minutes Day 1 Cisplatin 100mg/m2 or Carboplatin AUC 5 day 1-4 5-Fluorouracil 1000 mg/m2 iv 24 h maintenance treatment thereafter with cetuximab 500 mg/m2 every second week until PD or toxicity
Receives: Drug: Cetuximab
Arm B: cetuximab paclitaxel and carboplatinExperimentalArm B day 1 Cetuximab 400 mg/m2 iv 120 minutes Day 8 and 15 Cetuximab 250 mg/m2 iv 60 minutes day 1 Paclitaxel 175 mg/m2 day 1 Carboplatin AUC 5 treatment for 6 cycles thereafter maintenance treatment day 1 Cetuximab 500 mg/m2 every second week treatment until progress or unacceptable toxicity
Receives: Drug: Cetuximab

What is being measured

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

  1. Progression free survival

    To investigate in patients with relapsed or metastatic squamous cell carcinoma of the head and neck whether progression free survival (PFS) in the arm with cetuximab, paclitaxel and carboplatin based chemotherapy is not markedly worse than PFS in the arm with cetuximab and 5-FU, cisplatin or carboplatin based chemotherapy.

    Measured: 3 years

Secondary outcomes (1)

  1. Best overall response

    To compare in patients with relapsed or metastatic squamous cell carcinoma of the head and neck the following study variables between both treatment arms:

    • Best overall response
    • Duration of response
    • Time to treatment failure
    • Overall survival
    • Safety

    Measured: 3 years

Timeline

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

  1. First posted12 Apr 2013 (estimated)
  2. Study startNov 2011
  3. Primary completionNov 2013 (estimated)
  4. Study completionNov 2015 (estimated)

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
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01830556
Sponsor's protocol ID
CETMET study
Acronym
CETMET
Status last verified
May 2013
First submitted
10 Apr 2013
Last updated
21 May 2013
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cetuximab in people with Squamous Cell Carcinoma of the Head and Neck, run by Karolinska University Hospital at 5 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 10 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 21 May 2013. 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 Sweden, Denmark. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 3 years). 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 NCT01830556.

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 21 May 2013.

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