DOCETAXEL(XRP6976)
Drugdocetaxel 75mg/m2 by intravenous infusion over 60 minutes on Day 1 of a 3-week cycle
NCT Number: NCT00916097
Primary Objective:
To estimate the overall response rate after neo-adjuvant chemotherapy of Docetaxel 75 mg/m2 in combination with Cisplatin 75 mg/m2 given for 3 cycles, and followed by conventional radiotherapy in UCNT.
Secondary Objectives:
To evaluate:
* The radiological response after chemotherapy and radiotherapy * The pathological response after chemotherapy by cavum biopsy
To estimate:
* The duration of overall response * The time to progression (T.T.P)
To analyze:
* The overall survival * The safety profile
Looking for future studies?
Notify Me20 year–75 year
All sexes
Interventional
Phase 2
Sanofi-Aventis Administrative Office, Algiers, Algeria
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
docetaxel 75mg/m2 by intravenous infusion over 60 minutes on Day 1 of a 3-week cycle
Time frame: on day 21 of each treatment cycle for neoadjuvant chemotherapy, on day 64 and day 71 (3 to 4 weeks after the third chemotherapy)
Time frame: from baseline to the end of the study
Time frame: between day 64 and day 71 of the treatment
Time frame: from baseline to the end of the study
Time frame: from baseline to the end of the study
Time frame: from baseline to the end of the study
Sanofi
Industry
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)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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