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

Phase 1/Phase 2
18 Years
Open (Enrolling)
Head and Neck Cancer

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Trial Information

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

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.

Inclusion Criteria:

- 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)

- 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

Exclusion Criteria:

- 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.

- Weight loss greater than 20 % of usual body weight in the 3 months preceding trial

- High risk for poor compliance with therapy or follow up as assessed by the

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and Feasibility

Outcome 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.

Safety Issue:


Principal Investigator

June Corry

Investigator Role:

Study Chair

Investigator Affiliation:

Peter MacCallum Cancer Centre, Australia


Australia: Human Research Ethics Committee

Study ID:

TROG 07.04



Start Date:

April 2008

Completion Date:

June 2013

Related Keywords:

  • Head and Neck Cancer
  • Head and Neck
  • Cetuximab
  • Carboplatin
  • Radiotherapy
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms