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Head and Neck CancerPhase 1/2NCT00704639

Chemoradiation Treatment for Head and Neck Cancer

A Phase 1/2 study testing Cetuximab, Carboplatin and Radiotherapy in people with Head and Neck Cancer, run by Trans Tasman Radiation Oncology Group at 1 site in Australia.

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 a Phase II study of cetuximab, carboplatin and radiotherapy (RT) in patients with Locally Advanced Head and Neck Carcinomas (LAHNC) who are unfit for cisplatin. The aim of this study is to show the feasibility and safety profile of the combination of cetuximab, carboplatin and RT in treatment of patients with… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
Cetuximab, Carboplatin and Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteAustralia
Study dates
Apr 2008to Dec 2015
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Previously untreated SCC of the oropharynx, larynx or hypopharynx.
  • Stage III or IV, excluding T1N1, and metastatic disease (to be confirmed by a chest CT, and abdominal CT or ultrasound scan if patients with abnormal liver function tests or a bone scan or FDG-PET if patients with bone pain).
  • Histologically or cytologically confirmed HNSCC
  • Disease must be considered potentially curable by chemoradiation
  • Patients medically unfit for cisplatin chemotherapy due to one or more of the following reasons:
  • Clinically significant sensori-neural hearing impairment (audiometric abnormalities without corresponding clinical deafness will not be regarded as a contraindication to cisplatin)
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  • Severe tinnitus
  • Renal impairment (GFR < 60ml/min)
  • Peripheral neuropathy > grade 2
  • Inability to tolerate intravenous hydration eg due to cardiac disease
  • Co-morbidities (based on clinical judgement by the investigator) associated with ECOG PS 2 that in the view of the investigator would preclude the safe administration of cisplatin
  • Performance status ECOG 0, 1 or 2.
  • Adequate haematological, renal and hepatic functions as defined by:
  • Absolute neutrophil count (ANC, segmented cells (segs) + bands)>= 1.5 x 109/L
  • Platelet count >= 100 x 109/L
  • Total bilirubin <= 1.5 x upper normal limit
  • Alanine aminotransferase <= 2.5 x upper normal limit
  • Calculated creatinine clearance > 40ml/min (Cockcroft-Gault formula).
  • If calculated creatinine clearance < 50 ml/min, glomerular filtration rate to be measured with DTPA or EDTA scan. If < 40 ml/min not eligible.
  • Age >18 years
  • Signed written consent
  • Suitable for follow-up for 4 years in the view of the investigator

Who cannot join

  • Distant metastases, i.e., any metastatic disease below the clavicles. Patients with lung nodules >10mm will be excluded unless non-malignancy aetiology is established. Patients with lesions 5-10mm can be included if a FDG-PET scan is negative and the investigator considers on clinical grounds that metastasis is unlikely. Patients with lesions < 5mm can be included if the investigator considers on clinical grounds that metastases are unlikely. Patients with multiple lung nodules should not be included unless there is a strong case that these do not represent metastases, e.g., stable on imaging for over 12 months, non-malignant aetiology apparent. The level of clinical suspicion may be influenced by clinical stage, e.g., N3 disease, low neck nodes. In general if there is any doubt patients should be excluded.
  • Previous radical RT to the head \& neck region, excluding superficial RT for a non-melanomatous skin cancer.
  • Patients with prior cancers, except: those diagnosed > 5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of less than 5%; or successfully treated non-melanoma skin cancer; or carcinoma in situ of the cervix.
  • Significant intercurrent illness that will interfere with the chemotherapy or radiation therapy such as HIV infection, cardiac failure, pulmonary compromise, active infection
  • Any history of myocardial infarction, ventricular arrhythmias, or unstable angina within the last 6 months
  • Pregnant or lactating women.
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  • Weight loss greater than 20 % of usual body weight in the 3 months preceding trial entry
  • High risk for poor compliance with therapy or follow up as assessed by the investigator
  • Prior radiation to greater than 30% of the bone marrow
  • Prior systemic chemotherapy for cancer
  • Refusal by male or female patients, to use appropriate contraception during the study and for 3 months afterwards
  • Any condition or circumstance which might prevent the patient being able to give valid informed consent, or from completing participation in the study

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3002

Other trials in Australia

About this study

Official title: A Phase II Study of Cetuximab, Carboplatin and Radiotherapy for Locally Advanced Head and Neck Squamous Cell Carcinoma

This is a Phase II study of cetuximab, carboplatin and radiotherapy (RT) in patients with Locally Advanced Head and Neck Carcinomas (LAHNC) who are unfit for cisplatin.

The aim of this study is to show the feasibility and safety profile of the combination of cetuximab, carboplatin and RT in treatment of patients with LAHNC.

Read the detailed description

Secondary objectives are to estimate failure free survival (FFS) and overall survival, to evaluate the time to local and regional failure and to determine the site of first failure (characterised as local, regional, distant or combinations). Acute and late treatment toxicities will also be evaluated.

Being tested
Cetuximab, Carboplatin, Radiotherapy
Keywords
Head and Neck, Cetuximab, Carboplatin, Radiotherapy
Medical subject headings
Head and Neck Neoplasms

What participants receive

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

  • CetuximabDrug

    Also called Erbitux

    Patients will receive weekly intravenous cetuximab (initial dose 400mg/m2 in the week prior to commencing radiotherapy, then weekly 250mg/m2)for the duration of the radiotherapy

  • CarboplatinDrug

    Also called Paraplatin

    Weekly intravenous carboplatin (AUC 2) for the duration of the RT

  • RadiotherapyRadiation

    The radiotherapy schedule will be the "infield boost" (IFB) regimen, that is 66 Gy in 35 fractions over 5 weeks: daily for 3 weeks, then twice daily for 2 weeks (or 70 Gy in 35 fractions over 7 weeks for a specific subgroup of patients where IFB is not recommended).

Study groups in NCT00704639
Study groupRoleWhat they receive
Single armExperimentalChemoradiation (Cetuximab, Carboplatin and Radiotherapy)
Receives: Drug: Cetuximab; Drug: Carboplatin; Radiation: Radiotherapy

What is being measured

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

  1. Safety and Feasibility

    Measured: An initial 6 patients will be treated. Once all these patients have a 2 week post RT review there will be analysis. If <= 1 patient has a DLT than the treatment is deemed safe.

Secondary outcomes (5)

  1. Failure free survival (FFS)

    Measured: All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.

  2. Time to local and/or regional failure

    Measured: All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.

  3. Overall survival

    Measured: All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.

  4. Site of first failure

    Measured: All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.

  5. Acute and late treatment toxicities

    Measured: All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.

Timeline

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

  1. First posted25 Jun 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionDec 2014
  4. Study completionDec 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00704639
Sponsor's protocol ID
TROG 07.04
Status last verified
Jul 2017
First submitted
22 Jun 2008
Last updated
12 Jul 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Cetuximab, Carboplatin and Radiotherapy in people with Head and Neck Cancer, run by Trans Tasman Radiation Oncology Group at 1 site in Australia.

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 22 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: finished, as of the sponsor's last update on 12 Jul 2017. 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 Australia. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Safety and Feasibility (time frame: An initial 6 patients will be treated. Once all these patients have a 2 week post RT review there will be analysis. If <= 1 patient has a DLT than the treatment is deemed safe.). 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 NCT00704639.

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 12 Jul 2017.

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