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Docetaxel in Head and Neck Cancer
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Phase
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Status
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Age
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Protocol IDs
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Phase III, Phase II
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Treatment
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Closed
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18 and over
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Pharmaceutical / Industry
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XRP6976F/2503
NCT00261703
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Trial Description
Summary Primary Objective: - Phase II: To determine the best treatment scheme (TPF vs. PF).
- Phase III: To compare the time to progression at the 3 arms.
Secondary objectives: - To evaluate the safety at the 3 arms.
- To compare the progression at the 3 arms.
Eligibility Criteria Inclusion Criteria: - Head and Neck cancer locally advanced (oral cavity, pharynx, larynx), but without evident metastasis.
- Inoperable tumor after revision by a multidisciplinary oncology team.
- Proved epidermoid carcinoma.
- Good hematologic function (i.e, hemoglobin > 10 g/dl, ...)
- Good hepatologic 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.
Trial Contact Information
Trial Lead Organizations/Sponsors Sanofi-Aventis - US - Bridgewater | JOSÉ Mª TABOADA | | Study Director |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00261703
Information obtained from ClinicalTrials.gov on July 16, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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