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Study of Combination Docetaxel and Radiotherapy With or Without Cisplatin to Treat Local Advanced Head and Neck Cancer (TAX200006)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00521521
Recruitment Status : Completed
First Posted : August 28, 2007
Last Update Posted : December 7, 2009
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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).

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Drug: docetaxel and cisplatin Drug: docetaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2001
Actual Primary Completion Date : May 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: docetaxel and cisplatin Drug: docetaxel and cisplatin
Experimental: docetaxel Drug: docetaxel

Primary Outcome Measures :
  1. Objective response rates [ Time Frame: evaluated 8 weeks after the end of radiotherapy ]

Secondary Outcome Measures :
  1. Duration of the responses and overall survival [ Time Frame: time until progression ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00521521

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Paris, France
Sponsors and Collaborators
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Study Director: Marie SEBILLE, Dr. Sanofi

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Responsible Party: Medical Affairs Study Director, sanofi-aventis Identifier: NCT00521521     History of Changes
Other Study ID Numbers: TAX_FR1_236
First Posted: August 28, 2007    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action