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

Head and Neck Neoplasms Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00916097
• Other study ID #: XRP6976F_2502
• Status: Completed
• Phase: Phase 2
• First received: June 5, 2009
• Last updated: June 23, 2009
• Start date: July 2002
• Est. completion date: November 2005

Study information

• Verified date: June 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Tunisia: Office of Pharmacies and Medicines
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 2005
• Est. primary completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Head and Neck Neoplasms

Intervention

Drug:
• DOCETAXEL(XRP6976)
docetaxel 75mg/m2 by intravenous infusion over 60 minutes on Day 1 of a 3-week cycle

Locations

Country	Name	City	State
Algeria	Sanofi-Aventis Administrative Office	Alger
Morocco	Sanofi-Aventis Administrative Office	Casablanca
Tunisia	Sanofi-Aventis Administrative Office	Megrine

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Algeria,  Morocco,  Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Evaluation of the radiological response after chemotherapy and radiotherapy		from baseline to the end of the study	No
Secondary	Evaluation of the pathological response after chemotherapy		between day 64 and day 71 of the treatment	No
Secondary	Overall response duration		from baseline to the end of the study	No
Secondary	Estimation of the time to progression		from baseline to the end of the study	No
Secondary	Overall survival		from baseline to the end of the study	No