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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00521521
First received: August 27, 2007
Last updated: December 4, 2009
Last verified: December 2009
  Purpose

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 Intervention Phase
Head and Neck Neoplasms
Drug: docetaxel and cisplatin
Drug: docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Objective response rates [ Time Frame: evaluated 8 weeks after the end of radiotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Duration of the responses and overall survival [ Time Frame: time until progression ] [ Designated as safety issue: Yes ]

Enrollment: 86
Study Start Date: July 2001
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: docetaxel and cisplatin Drug: docetaxel and cisplatin
Experimental: docetaxel Drug: docetaxel

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00521521

Locations
France
Sanofi-Aventis
Paris, France
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Marie SEBILLE, Dr. Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00521521     History of Changes
Other Study ID Numbers: TAX_FR1_236
Study First Received: August 27, 2007
Last Updated: December 4, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014