Status:
COMPLETED
Docetaxel in Head and Neck Cancer
Lead Sponsor:
Sanofi
Conditions:
Head and Neck Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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: * ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
439 Patients enrolled
Trial Details
Trial ID
NCT00261703
Start Date
December 1 2002
End Date
July 1 2010
Last Update
May 11 2012
Active Locations (2)
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1
Sanofi-Aventis
Porto Salvo, Portugal
2
Sanofi-Aventis
Barcelona, Spain