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Squamous Cell Head and Neck CarcinomaPhase 2TPExNCT01289522

Chemotherapy With Cetuximab in Treating Patients With Recurrent or Metastatic Head and Neck Cancer

A Phase 2 study testing cetuximab IV and Biopsies in people with Squamous Cell Head and Neck Carcinoma and Recurrent or Metastatic Disease, run by Groupe Oncologie Radiotherapie Tete et Cou 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

PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas. Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck cancer. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
cetuximab IV and Biopsies
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
14 sitesin 2 countries
Study dates
Sep 2009to Jan 2014
Phase
Phase 2
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven squamous cell carcinoma of the oral cavity, larynx, oropharynx or hypopharynx
  • Recurrent disease, incurable disease as determined by surgery or radiation, or metastatic disease
  • Measurable or evaluable disease
  • Age > 18 years and <= 70 years
  • WHO performance status 0 or 1
  • Absolute neutrophil count > 1,500/mm3
Show all 14Show fewer
  • Platelets > 150,000/mm3
  • Total Bilirubin <= institutional upper limit of normal
  • Aspartate aminotransferase < 1.5 X institutional upper limit of normal
  • Alanine aminotransferase < 1.5 X institutional upper limit of normal
  • Alkaline phosphatase < 2.5 X institutional upper limit of normal
  • creatinine clearance > 60 mL/min
  • Signed informed consent
  • Women of child-bearing potential and men must be willing and able practice adequate contraception prior to study entry and for the duration of study treatment

Who cannot join

  • Previous chemotherapy. Chemotherapy given as part of initial curative therapy and completed more than 6 months before inclusion is allowed
  • Previous treatment with total doses of cisplatin > 300 mg/ m2
  • Patients must not have any co-existing disease that would preclude cisplatin administration, such as peripheral neuropathy or renal failure
  • Surgery (excluding biopsy) or radiotherapy within 4 weeks prior to study entry
  • Nasopharyngeal carcinoma, or cancer of sinusal cavities
  • Active infection including tuberculosis or HIV positive patient
Show all 21Show fewer
  • Other malignancy within last 5 years except for non-melanoma skin cancer
  • No other investigational agent within 30 days prior to study entry
  • No other concurrent chemotherapy, immunotherapy, antitumor hormonal therapy (excluding contraceptives and replacement steroids), radiotherapy, or experimental medications
  • No prior anti EGFR therapy
  • No known brain metastases
  • Uncontrolled intercurrent illness that would prevent delivery of protocol therapy
  • Patients with a prior history of basal cell carcinoma of the skin or in situ carcinoma of the cervix must have been curatively treated and must have remained disease free for 5 years post diagnosis
  • No history of hypersensitivity reaction to drugs on study
  • No unstable angina or myocardial infarction within the past 12 months
  • No symptomatic congestive heart failure or New York Heart Association (NYHA) class II-IV heart disease
  • No serious uncontrolled cardiac arrhythmia
  • No other prior or concomitant squamous cell carcinoma
  • No other prior or concomitant cancer, except curatively treated basal carcinoma of the skin or in situ cervical cancer, for which the patient has been curatively treated and remains disease-free for the past 5 years
  • Patient is pregnant or lactating
  • Patients must not have any co-existing condition that would preclude full compliance with the study

Trial locations and contacts

14 sites in 2 countries.

14 sites in 2 countries

France11 sites

  • Hôpital Saint André

    Bordeaux

  • Centre Jean Perrin,

    Clermont-Ferrand

  • Centre G-F Leclerc

    Dijon

  • Centre Hospitalier de la Dracénie

    Draguignan

  • Centre Hospitalier de Bretagne Sud

    Lorient

  • Centre Léon Bérard

    Lyon

  • Hôpital de la Timone

    Marseille

  • Centre Henri Becquerel

    Rouen

  • Hôpital Foch

    Suresnes

  • CHU Bretonneau

    Tours

  • Institut Gustave Roussy

    Villejuif

Other trials in France

Belgium3 sites

  • Cliniques Universitaires

    Brussels

  • Clinique Sainte Elisabeth

    Namur

  • Clinique universitaire de Mont Godinne UCL

    Yvoir

Other trials in Belgium

About this study

Official title: Phase II Study of Cetuximab, Docetaxel and Cisplatin as First-line Treatment in Patients With Metastatic or Recurrent Head and Neck Squamous Cell Carcinomas - GORTEC 2008-03 TPEx

PURPOSE: Cetuximab with platinum and 5FU is now the standard combination as first-line treatment in patients with metastatic or recurrent Head and Neck squamous cell carcinomas. Cetuximab and taxane combinations have demonstrated promising activity in Head and Neck cancer. This phase II trial is studying new cetuximab, docetaxel and cisplatin combination named TPEx as first-line treatment in this setting.

Read the detailed description

OBJECTIVES:

Primary

  • To determine the efficacy of TPEx combination in patients with head and neck cancer in term of objective response rate (RECIST, see statistical consideration) Secondary
  • To assess toxicities of TPEx combination
  • Determine the efficacy of TPEx combination in patients with head and neck cancer: Best Overall Response , progression-free survival and survival.
  • Translational research objective:To better understand the mechanisms of chemoresistance and to identify biomarkers by the analysis of the tumor biopsies (RNA, gene expression profile) and protein profile (plasma samples). Exploratory analyses.

OUTLINE: This is an open-label phase II, multicenter study. Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according to the patient or the investigator. Tumor check-up will be performed every 6 weeks. This study will allow translational research with blood sample and biopsies at baseline before any treatment, during the treatment with TPEx combination (week 6).,After completion of study treatment, patients are followed every 2 months.

Being tested
cetuximab IV, Biopsies
Keywords
Squamous cell carcinoma of the head and neck, recurrent or metastatic, first line chemotherapy, cetuximab, docetaxel, cisplatin, antineoplastic agents, First Line Palliative Treatment
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Recurrence, Neoplasm Metastasis

What participants receive

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

  • cetuximab IVBiological

    • Cetuximab 400 mg/m² over 120 minutes on day 1 of cycle 1 only.
    • Cetuximab dose will be 250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.
    • Cetuximab dose will be 500mg/m2 IV every 2 weeks during the maintenance therapy.

    Drug: Cisplatin IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles

    Drug: Docetaxel IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles

    G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.

  • BiopsiesOther

    No intervention, only biopsy for translational project.

Study groups in NCT01289522
Study groupRoleWhat they receive
cetuximabExperimentalPatients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according
Receives: Biological: cetuximab IV; Other: Biopsies

What is being measured

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

  1. Objective Tumor Response Rate

    The objective tumor response rate is evaluated every 6 weeks according to RECIST criteria.

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT-scan or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.

    Measured: 12 weeks (after completion of the 4th cycle of chemotherapy)

Secondary outcomes (5)

  1. Grade 1 to 5 Toxicity

    All grade 1 to 5 toxicity are registered during treatment. Patients have weekly clinical and biological examination.

    Measured: 24 weeks (average)

  2. Best Overall Response

    Tumor response is evaluated every 6 weeks according to RECIST criteria. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions, Stable Disease (SD); Best overall Response = CR + PR + SD.

    Measured: 12 weeks

  3. Progression-free Survival

    Measured: 1 year

  4. Overall Survival

    Measured: 1 year

  5. Biomarkers

    Measured: two years

Timeline

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

  1. First posted3 Feb 2011 (estimated)
  2. Study startSep 2009
  3. Primary completionJan 2014
  4. Study completionJan 2014

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
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01289522
Sponsor's protocol ID
GORTEC 2008-03 TPEx
Other IDs
2008-004869-25, 2008
Acronym
TPEx
Status last verified
Oct 2016
First submitted
1 Feb 2011
Last updated
15 May 2017
Data monitoring committee
No

Publications

  • Guigay J, Fayette J, Dillies AF, Sire C, Kerger JN, Tennevet I, Machiels JP, Zanetta S, Pointreau Y, Bozec Le Moal L, Henry S, Schilf A, Bourhis J. Cetuximab, docetaxel, and cisplatin as first-line treatment in patients with recurrent or metastatic head and neck squamous cell carcinoma: a multicenter, phase II GORTEC study. Ann Oncol. 2015 Sep;26(9):1941-1947. doi: 10.1093/annonc/mdv268. Epub 2015 Jun 24.

    PubMed 26109631

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing cetuximab IV and Biopsies in people with Squamous Cell Head and Neck Carcinoma and Recurrent or Metastatic Disease, run by Groupe Oncologie Radiotherapie Tete et Cou 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 14 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 15 May 2017. 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 France, Belgium. 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?

Yes. Results are posted in the registry (first posted 7 Apr 2017). 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?

Objective Tumor Response Rate (time frame: 12 weeks (after completion of the 4th cycle of chemotherapy)). 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 NCT01289522, 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 15 May 2017.

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