Study of Combination Docetaxel and Radiotherapy With or Without Cisplatin to Treat Local Advanced Head and Neck Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy of the concomitant combination of radiotherapy and docetaxel with or without cisplatin in terms of objective response rates (WHO criteria).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

• 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 surgery.

• 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.

Exclusion Criteria:

• 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.