Know Cancer

or
forgot password

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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Head and Neck Neoplasms

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response rates

Outcome Time Frame:

evaluated 8 weeks after the end of radiotherapy

Safety Issue:

No

Principal Investigator

Marie SEBILLE, Dr.

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

TAX_FR1_236

NCT ID:

NCT00521521

Start Date:

July 2001

Completion Date:

Related Keywords:

  • Head and Neck Neoplasms
  • Neoplasms
  • Head and Neck Neoplasms

Name

Location