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

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00521521

Purpose

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

Condition	Intervention	Phase
Head and Neck Neoplasms	Drug: docetaxel and cisplatin Drug: docetaxel	Phase II

MedlinePlus related topics: Cancer Head and Neck Cancer

Drug Information available for: Docetaxel Cisplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Objective response rates [ Time Frame: evaluated 8 weeks after the end of radiotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Duration of the responses and overall survival [ Time Frame: time until progression ] [ Designated as safety issue: Yes ]

Enrollment:	86
Study Start Date:	July 2001
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
docetaxel and cisplatin: Active Comparator	Drug: docetaxel and cisplatin
docetaxel: Experimental	Drug: docetaxel

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521521

Locations

France
Sanofi-Aventis
Paris, France

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Marie SEBILLE, Dr.

Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	TAX_FR1_236
Study First Received:	August 27, 2007
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00521521
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Docetaxel
Cisplatin
Head and Neck Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents

Therapeutic Uses
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009