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

NCT00916097 | Completed Phase 2

• 1 other identifier: XRP6976F_2502
• Study Type: interventional
• Target: 66
• Locations: 3 countries
• Sites: 3

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

Conditions

Head and Neck Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

1

EXPERIMENTAL

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

Drug: DOCETAXEL(XRP6976)

Interventions

DOCETAXEL(XRP6976) DRUG

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

1

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

Sanofi-Aventis Administrative Office

Algiers, Algeria

Location

Sanofi-Aventis Administrative Office

Casablanca, Morocco

Location

Sanofi-Aventis Administrative Office

Mégrine, Tunisia

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Christian Fassotte

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 5, 2009
• First Posted: June 9, 2009
• Study Start: July 1, 2002
• Primary Completion: November 1, 2005
• Study Completion: November 1, 2005
• Last Updated: June 24, 2009

Record last verified: 2009-06

Locations

AL (1); TU (1); MO (1)