A Multicenter Phase II Trial of Docetaxel Combined With Cisplatin (CDDP) as a Neo-Adjuvant Chemotherapy in Patients With Loco Regionally Advanced Undifferentiated Carcinoma of Nasopharyngeal Type (UCNT)
Inclusion Criteria
Inclusion criteria:
- Written or witnessed oral informed consent prior to beginning specific protocol
procedures >Histologically proven undifferentiated carcinoma of nasopharyngeal type
(UCNT- stage II-III OMS) at first diagnosis
- Staging of disease: stage III, IV A, IV B (UICC/AJCC, 1997 classification), any T,
N2 - N3 UCNT, without metastasis
- Adenopathy > 3 cm
- Patients are required to have an unidimensionally measurable disease with RECIST
method
- Performance status 1 or karnofsky index 3
- Previous therapy: Chemotherapy :none Radiation therapy: none Surgery: none
- Laboratory requirements
Exclusion criteria:
- Prior chemotherapy or / and radiotherapy
- Metastatic disease (M as per the UCCI/AJC classification)
- Past or current history of neoplasm other than UCNT, except for curatively treated
non melanoma skin cancer or in situ carcinoma of the cervix or other
cancer,curatively treated and with no evidence of disease at the previous 5 years
- Pregnant, or lacting, patients of childbearing potential must implement adequate
contraceptive measures during study participation
- Pre-existing motor or sensory neurotoxicity of a severity 3 grade 2 according to NCI
criteria
- Others serious illness or medical condition:
1.Congestive heart failure or unstable angina pectoris even if it is medically
controlled 2.Previous history of myocardial infraction within 1 year from study
entry 3.Uncontrolled hypertension or high risk uncontrolled arrhythmias
4.Uncontrolled peptic ulcer, unstable diabetes mellitus susceptible to contraindicate
any use of corticoids 5.Concomitant treatment with corticoids initiated > 6 months
prior to study entry is given to the dose of methylprednisolone or equivalent 3 20 mg
6.Definite contraindications for the use of Corticoids 7.Concurrent treatment with
other experimental drugs 8.Participation in another clinical with any investigational
drug within 30 days prior to study entry 9.Performance status = 2,3,4 or karnofsky
index < 80 10. History of significant neurologic or psychiatric disorders including
psychotic disorders, dementia or seizures that would prohibit the understanding and
giving of informed consent
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.