Chemoradiation Treatment for Head and Neck Cancer

NCT00704639 | Completed Phase 1

• 1 other identifier: TROG 07.04
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck; Cetuximab; Carboplatin; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Safety and Feasibility

  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)

• 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.

• 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.

Study Arms (1)

Single arm

EXPERIMENTAL

Chemoradiation (Cetuximab, Carboplatin and Radiotherapy)

Drug: Cetuximab; Drug: Carboplatin; Radiation: Radiotherapy

Interventions

Cetuximab DRUG

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

Also known as: Erbitux

Single arm

Carboplatin DRUG

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

Also known as: Paraplatin

Single arm

Radiotherapy RADIATION

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).

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Trans Tasman Radiation Oncology Group: lead

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3002, Australia

Location

Related Links

• Click here for more information about this study on the TROG official website

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Cetuximab; Carboplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Therapeutics

Study Officials

• June Corry

  Peter MacCallum Cancer Centre, Australia

  STUDY CHAIR

• Danny Rischin

  Peter MacCallum Cancer Centre, Australia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2008
• First Posted: June 25, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

AU (1)