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

Head and Neck Neoplasms Clinical Trial

— TAX200006  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00521521
• Other study ID #: TAX_FR1_236
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2007
• Last updated: December 4, 2009
• Start date: July 2001

Study information

• Verified date: December 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Drug:
• docetaxel and cisplatin

• docetaxel

Locations

Country	Name	City	State
France	Sanofi-Aventis	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rates		evaluated 8 weeks after the end of radiotherapy	No
Secondary	Duration of the responses and overall survival		time until progression	Yes