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

Primary Purpose

Head and Neck Neoplasms

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

docetaxel and cisplatin

docetaxel

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

docetaxel and cisplatin

docetaxel

Arm Description

Outcomes

Primary Outcome Measures

Objective response rates

Secondary Outcome Measures

Duration of the responses and overall survival

Full Information

NCT ID

NCT00521521

First Posted

August 27, 2007

Last Updated

December 4, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00521521

Brief Title

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

Acronym

TAX200006

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 Type

Interventional

2. Study Status

Record Verification Date

December 2009

Overall Recruitment Status

Completed

Study Start Date

July 2001 (undefined)

Primary Completion Date

May 2006 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

docetaxel and cisplatin

Arm Type

Active Comparator

Arm Title

docetaxel

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

docetaxel and cisplatin

Intervention Type

Drug

Intervention Name(s)

docetaxel

Primary Outcome Measure Information:

Title

Objective response rates

Time Frame

evaluated 8 weeks after the end of radiotherapy

Secondary Outcome Measure Information:

Title

Duration of the responses and overall survival

Time Frame

time until progression

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marie SEBILLE, Dr.

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis

City

Paris

Country

France

12. IPD Sharing Statement

Learn more about this trial

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

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