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

Trans Tasman Radiation Oncology Group1 site in 1 country60 target enrollmentApril 2008

ConditionsHead and Neck Cancer

InterventionsCetuximab Carboplatin Radiotherapy

DrugsCetuximab Carboplatin

Overview

Phase: Phase 1
Intervention: Cetuximab
Conditions: Head and Neck Cancer
Sponsor: Trans Tasman Radiation Oncology Group
Enrollment: 60
Locations: 1
Primary Endpoint: Safety and Feasibility
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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 LAHNC.

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.

Registry

clinicaltrials.gov

Start Date

April 2008

End Date

December 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Trans Tasman Radiation Oncology Group

Responsible Party

Sponsor

Eligibility Criteria

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

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 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

Arms & Interventions

Single arm

Chemoradiation (Cetuximab, Carboplatin and Radiotherapy)

Intervention: Cetuximab

Single arm

Chemoradiation (Cetuximab, Carboplatin and Radiotherapy)

Intervention: Carboplatin

Single arm

Chemoradiation (Cetuximab, Carboplatin and Radiotherapy)

Intervention: Radiotherapy

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Site of first failure(All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.)
Acute and late treatment toxicities(All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.)
Failure free survival (FFS)(All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.)
Time to local and/or regional failure(All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.)
Overall survival(All patients will be followed until the last patient enrolled has a minimum follow up of 2 years post treatment.)