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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00916097
First received: June 5, 2009
Last updated: June 23, 2009
Last verified: June 2009
  Purpose

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

Condition Intervention Phase
Head and Neck Neoplasms
Drug: DOCETAXEL(XRP6976)
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the radiological response after chemotherapy and radiotherapy [ Time Frame: from baseline to the end of the study ] [ Designated as safety issue: No ]
  • Evaluation of the pathological response after chemotherapy [ Time Frame: between day 64 and day 71 of the treatment ] [ Designated as safety issue: No ]
  • Overall response duration [ Time Frame: from baseline to the end of the study ] [ Designated as safety issue: No ]
  • Estimation of the time to progression [ Time Frame: from baseline to the end of the study ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: from baseline to the end of the study ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: July 2002
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00916097

Locations
Algeria
Sanofi-Aventis Administrative Office
Alger, Algeria
Morocco
Sanofi-Aventis Administrative Office
Casablanca, Morocco
Tunisia
Sanofi-Aventis Administrative Office
Megrine, Tunisia
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Christian Fassotte Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00916097     History of Changes
Other Study ID Numbers: XRP6976F_2502
Study First Received: June 5, 2009
Last Updated: June 23, 2009
Health Authority: Tunisia: Office of Pharmacies and Medicines

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014