Docetaxel in Head and Neck Cancer

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary Objective:

• Phase II: To determine the best treatment scheme (TPF vs. PF).

• Phase III: To compare the time to progression and the treatment failure at the 3 arms.

Secondary objectives:

• To evaluate the safety at the 3 arms.

• To compare the progression , overall survival and locoregional control at the 3 arms.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Cisplatin; Docetaxel; Fluorouracil

Criteria

Inclusion Criteria:

• Head and Neck cancer locally advanced (oral cavity, oropharynx, hypopharynx or larynx) but without evident metastasis.

• Inoperable tumor after revision by a multidisciplinary oncology team.

• Proved epidermoid carcinoma.

• ECOG = 0-1

• Good hematologic function (i.e, hemoglobin > 10 g/dl, ...)

• Good hepatologic function

• Good renal function

Exclusion Criteria:

• Pregnant or breast-feeding women. Potential child-bearing women should use an effective conceptive method and should have a negative pregnancy test at least the week before entering the study.

• Nasopharynx, nasal cavity and paranasal sinusitis will be excluded

• Previous chemotherapeutic or radiotherapeutic treatment for this disease.

• Previous or current neoplasms in other locations, except in situ cervicouterine cancer properly treated or basal cell or squamous cell carcinoma

• Symptomatic peripheral neuropathy

• Other clinical severe diseases

• Concomitant treatment with corticoids within 6 months prior to inclusion.

• Concomitant treatment with any other neoplastic therapy

• Previous treatment for current disease.

• Loss of weight greater than 10% within the last 3 months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.