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

NCT00521521 | Completed Phase 2

• 1 other identifier: TAX_FR1_236
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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).

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• Objective response rates

  evaluated 8 weeks after the end of radiotherapy

Secondary Outcomes (1)

• Duration of the responses and overall survival

  time until progression

Study Arms (2)

docetaxel and cisplatin

ACTIVE COMPARATOR

Drug: docetaxel and cisplatin

docetaxel

EXPERIMENTAL

Drug: docetaxel

Interventions

docetaxel and cisplatin DRUG

docetaxel and cisplatin

docetaxel DRUG

docetaxel

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis

Paris, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Docetaxel; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Marie SEBILLE, Dr.

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 27, 2007
• First Posted: August 28, 2007
• Study Start: July 1, 2001
• Primary Completion: May 1, 2006
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

FR (1)