NPC Study : TAX + CIS Neoadjuvant in Patients With Loco Regionally Advanced Undifferentiated Carcinoma of Nasopharyngeal Type (UCNT)

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)

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

Study Overview

• Status: Completed
• Conditions: Head and Neck Neoplasms
• Intervention / Treatment: Drug: DOCETAXEL(XRP6976)

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• Algeria
  • Alger, Algeria
    • Sanofi-Aventis Administrative Office
• Morocco
  • Casablanca, Morocco
    • Sanofi-Aventis Administrative Office
• Tunisia
  • Megrine, Tunisia
    • Sanofi-Aventis Administrative Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; docetaxel 75mg/m2 in combination with cisplatin 75mg/m2 given every 3 weeks for 3 cycles	Drug: DOCETAXEL(XRP6976); docetaxel 75mg/m2 by intravenous infusion over 60 minutes on Day 1 of a 3-week cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of tumor response in patients with measurable disease according to RECIST criteria	on day 21 of each treatment cycle for neoadjuvant chemotherapy, on day 64 and day 71 (3 to 4 weeks after the third chemotherapy)

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the radiological response after chemotherapy and radiotherapy	from baseline to the end of the study
Evaluation of the pathological response after chemotherapy	between day 64 and day 71 of the treatment
Overall response duration	from baseline to the end of the study
Estimation of the time to progression	from baseline to the end of the study
Overall survival	from baseline to the end of the study

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Christian Fassotte, Sanofi

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Primary Completion (Actual): November 1, 2005
• Study Completion (Actual): November 1, 2005

Study Registration Dates

• First Submitted: June 5, 2009
• First Submitted That Met QC Criteria: June 5, 2009
• First Posted (Estimate): June 9, 2009

Study Record Updates

• Last Update Posted (Estimate): June 24, 2009
• Last Update Submitted That Met QC Criteria: June 23, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Head and Neck Neoplasms; Carcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel
• Other Study ID Numbers: XRP6976F_2502