A Multicenter, Randomized, Phase II Study of the Combination of Docetaxel (TAXOTERE) and Concomitant Radiotherapy With or Without Cisplatin in Patients With Locally Advanced Head and Neck Cancer
- Patients with locally advanced head and neck cancer (T3 and T4 tumors), epidermoid,
histologically proven without metastasis; the primitive site of which is the oral
cavity, the oropharynx, the hypopharynx or the larynx.
- Locally advanced tumors which are inoperable, or operable but the patient refuses
- Age ≥ 18 years and ≤ 70 years.
- PS < 2.
- Satisfactory hematological, hepatic and renal functions: (PN ≥ 2000/mm3, platelet
count ≥ 100,000/mm3, hemoglobin ≥ 10g/dl, serum creatinine ≤ 120 µmol/l or creatinine
clearance ≥ 60 ml/mn, normal total bilirubin, AST (SGOT) and ALT (SGPT) ≤ 2.5 x the
upper limit of normal (ULN) of each center, PAL ≤ 5 x LNS; patients with AST or ALT >
1.5 x LNS combined with PAL > 2.5 x LNS will not be eligible for this trial.
- Any metastases (other than cervical ganglia).
- Cancer of the cavum and the facial structure.
- Any previous chemotherapy or radiotherapy, irrespective of the reason.
- Any surgery for epidermoid carcinoma in the upper aerodigestive tracts.
- Weight loss ≥10% of total body weight during the last 3 months.
- Any other previous cancer excepting in situ or cutaneous cervical cancer
(spinocellular or basocellular).
- Pregnant or nursing women; women of childbearing potential must use an appropriate
method of contraception.
- Poorly controlled progressive infection.
- Peripheral neuropathy with NCI grade ≥ 2.
- Neurological or psychiatric disease (dementia, seizures, etc.) that is not compatible
with good understanding and sufficient compliance with treatment.
- Any other poorly controlled progressive disease, such as heart failure, symptomatic
cardiac rhythm disorders, progressive angina pectoris, or respiratory impairment.
- Any other concomitant investigational treatment.
- Any other concomitant anticancer treatment.
- Allergy to polysorbate 80.
- Definitive formal contraindication to corticosteroids.
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.