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

Sanofi1 site in 1 country86 target enrollmentJuly 2001

ConditionsHead and Neck Neoplasms

Interventionsdocetaxel and cisplatin docetaxel

Drugsdocetaxel and cisplatin docetaxel

Overview

Phase: Phase 2
Intervention: docetaxel and cisplatin
Conditions: Head and Neck Neoplasms
Sponsor: Sanofi
Enrollment: 86
Locations: 1
Primary Endpoint: Objective response rates
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

July 2001

End Date

May 2006

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sanofi

Eligibility 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.
•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 ≥
•Neurological or psychiatric disease (dementia, seizures, etc.) that is not compatible with good understanding and sufficient compliance with treatment.