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

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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 material for EGFR status and downstream signaling.
- Stage III or IV.
- Absence of distant metastasis
- Patients who have unresectable disease
- No prior treatment for head and neck cancer
- No nasopharynx, nasal and paranasal cancer
- Age 18-75
- 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 *mol/l (< 1.36mg/dl) and calculated CrCl * 60ml/min
- Patients having 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.
- 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 can only be registered/randomized in this trial once.

Exclusion Criteria

see above

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint will be to determine the feasibility of regimens assessed on<br /><br>at least 80% of the per protocol dose intensity of the radiotherapy, the<br /><br>platinum and cetuximab during the chemo-radiation part of treatment. If<br /><br>delays and/or dose reductions lead to less than 80% dose intensity for at least<br /><br>one of these three treatments, the patient will be counted as a failure for<br /><br>this criterion.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints will be toxicity, dose modifications, response rate.<br /><br>Safety Common Terminology Criteria for Adverse Events (CTCAE), version 3.0</p><br>

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