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

Primary Purpose

Head and Neck Neoplasms

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

DOCETAXEL(XRP6976)

About this trial

This is an interventional treatment trial for Head and Neck Neoplasms

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

docetaxel 75mg/m2 in combination with cisplatin 75mg/m2 given every 3 weeks for 3 cycles

Outcomes

Primary Outcome Measures

Evaluation of tumor response in patients with measurable disease according to RECIST criteria

Secondary Outcome Measures

Evaluation of the radiological response after chemotherapy and radiotherapy

Evaluation of the pathological response after chemotherapy

Overall response duration

Estimation of the time to progression

Overall survival

Full Information

NCT ID

NCT00916097

First Posted

June 5, 2009

Last Updated

June 23, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00916097

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2009

Overall Recruitment Status

Completed

Study Start Date

July 2002 (undefined)

Primary Completion Date

November 2005 (Actual)

Study Completion Date

November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

Brief Summary

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

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

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

docetaxel 75mg/m2 in combination with cisplatin 75mg/m2 given every 3 weeks for 3 cycles

Intervention Type

Drug

Intervention Name(s)

DOCETAXEL(XRP6976)

Intervention Description

docetaxel 75mg/m2 by intravenous infusion over 60 minutes on Day 1 of a 3-week cycle

Primary Outcome Measure Information:

Title

Evaluation of tumor response in patients with measurable disease according to RECIST criteria

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)

Secondary Outcome Measure Information:

Title

Evaluation of the radiological response after chemotherapy and radiotherapy

Time Frame

from baseline to the end of the study

Title

Evaluation of the pathological response after chemotherapy

Time Frame

between day 64 and day 71 of the treatment

Title

Overall response duration

Time Frame

from baseline to the end of the study

Title

Estimation of the time to progression

Time Frame

from baseline to the end of the study

Title

Overall survival

Time Frame

from baseline to the end of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Fassotte

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Alger

Country

Algeria

Facility Name

Sanofi-Aventis Administrative Office

City

Casablanca

Country

Morocco

Facility Name

Sanofi-Aventis Administrative Office

City

Megrine

Country

Tunisia

12. IPD Sharing Statement

Learn more about this trial

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

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