Study of Combination Docetaxel and Radiotherapy With or Without Cisplatin to Treat Local Advanced Head and Neck Cancer (TAX200006)

Sanofi

Status and phase

Completed

Phase 2

Conditions

Head and Neck Neoplasms

Treatments

Drug: docetaxel

Drug: docetaxel and cisplatin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00521521

TAX_FR1_236

Details and patient eligibility

About

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

Enrollment

86 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.