Randomized phase II feasibility study of Cetuximab combined with 4 cycles of TPF followed by platinum based chemo-radiation strategies

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

- Histologically proven newly diagnosed unresectable squamous cell carcinoma of the head and neck.
¨ Patients who have uni- or bidimensionally measurable disease.
¨ Patients must consent to access of their skin and tumor material for EGFR status and downstream signaling.
¨ Stage III or IV.
¨ Absence of distant metastasis
¨ No prior treatment for head and neck cancer
¨ No nasopharynx and paranasal cancer
¨ Age 18-75
- WHO Performance Status 0 or 1
¨ WHO Performance Status 0 or 1
¨ Normal hematological functions: neutrophils = 1.5 x109 cells/l, platelets = 100 x109 cells/l.
¨ Normal liver functions: bilirubin = 1.5 times the upper limit of the normal range; alkaline
phosphatase and transaminases = 2.5 times the upper limit of the normal range.
¨ Serum creatinine = 120 µmol/l (1.36 mg/dl) and calculated CrCl = 60ml/min.
¨ Normal cardiac function(LVEF = 50%), clinically satisfactory 12 lead ECG, and in the past 6
months no serious cardiac illness or medical condition
¨ All patients (male and female) must use effective contraception methods according to
CPMP/ICH/286/95 if of reproductive potential (e.g. implants, injectables, combined oral
contraceptives, IUDs, sexual abstinence or vasectomised partner).
¨ Females must not be pregnant or lactating.
¨ No current malignancies at other sites with the exception of cone biopsied carcinoma of the
cervix and adequately treated basal or squamous cell skin carcinoma or other cancer from which
the patient has been disease-free for at least last five years.
¨ Absence of any unstable systemic diseases or active uncontrolled infections.
EORTC 24061 Phase II feasibility study of cetuximab in HNSCC
Version 1.0 24 / 95 18 January, 2007
¨ Patients may not receive any anticancer therapy, or other investigational agents while on study.
¨ Absence of any psychological, familial, sociological or geographical condition potentially
hampering compliance with the study protocol and follow-up schedule; those conditions should
be assessed with the patient before registration in the trial.
¨ Before patient registration/randomization, written informed consent must be given according to
ICH/GCP, and national/local regulations.
¨ Patients must consent to mandatory translational research project for skin biopsies.
There is no reason to believe that the representation of males and females would differ in the studied population, therefore no specific stratification is performed to ensure gender distribution.
Patients are informed on the use of their coded data. If the patient refuses to have his/her data used, he/she cannot sign the informed consent and cannot be included in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- pregnant or lactating females
- malignancies at other sites with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma or other cancer from which the patient has been disease-free for at least last five years
- Presence of any unstable systemic diseases or active uncontrolled infections.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to select one of two platinum strategies to be used<br>in this regimen for use as experimental arm in Phase III. This is a screening feasibility study addressing purely investigational approaches.;Secondary Objective: Explore which factors related to EGFR predict the biological activity of cetuximab, i.e. which patients will benefit from the addition of cetuximab to both induction chemotherapy and chemoradiation;Primary end point(s): Primary endpoint will be to determine the feasibility of regimens assessed on at least 80% of the per<br>protocol dose intensity of the radiotherapy, the platinum and cetuximab during the chemo-radiation<br>part of treatment. If delays and/or dose reductions lead to less than 80% dose intensity for at least<br>one of these three treatments, the patient will be counted as a failure for this criterion.

Secondary Outcome Measures

Name	Time	Method

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