Taxotere (Docetaxel) New Indication: Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treatment Registration Trial

This study is currently recruiting participants.
Verified January 2014 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00995293
First received: September 22, 2009
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

The Primary Objective is to evaluate the progression-free survival after treatment with docetaxel plus cisplatin plus 5-Fluorouracil (5-FU) (DCF) in comparison with cisplatin plus 5-FU (CF) in patient with locally advanced inoperable SCCHN The Secondary Objective is to evaluate and compare the clinical response rate both before and after radiotherapy, the local symptoms, the duration of response, the time to treatment failure, the survival, the toxicity and the quality of life in the 2 study groups.


Condition Intervention Phase
Head and Neck Neoplasms
Drug: DOCETAXEL
Drug: CISPLATIN
Drug: 5-FLUOROURACIL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Parallel-group, Multicenter Study of Neoadjuvant Docetaxel(Taxotere®) Plus Cisplatin Plus 5-fluorouracil Versus Neoadjuvant Cisplatin Plus 5-fluorouracil in Patients With Locally Advanced Inoperable Squamous Cell Carcinoma of the Head and Neck

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: From randomization to patient death (follow-up every 3 months 1st year, then every 6 months) ] [ Designated as safety issue: No ]
  • Overall response rates [ Time Frame: From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months) and at the end of chemotherapy + end of radiotherapy ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months) ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: From randomization to any progression event or patient death (follow-up every 3 months 1st year, then every 6 months) and at the end of chemotherapy + end of radiotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: August 2009
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel Cisplatin 5-Fluorouracil (DCF)

4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment):

  • Docetaxel 60mg/m² on day 1
  • Cisplatin 75mg/m² on day 1
  • 5-FU 750mg/m²/day on day 1 to day 5
Drug: DOCETAXEL
Intravenous
Drug: CISPLATIN
Intravenous
Drug: 5-FLUOROURACIL
Intravenous
Experimental: Cisplatin 5-Fluorouracil (CF)

4 cycles of the following products every 3 weeks (unless disease progression/relapse or unacceptable toxicity occured or the patient refused treatment):

  • Cisplatin 75mg/m² on day 1
  • 5-FU 750mg/m²/day on day 1 to day 5
Drug: CISPLATIN
Intravenous
Drug: 5-FLUOROURACIL
Intravenous

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Tumor type: Histologically or cytologically proven squamous cell carcinoma of the head and neck (SCCHN) presenting with locally advanced disease at diagnosis. Primary tumor sites eligible are: oral cavity, oropharynx, hypopharynx and larynx.
  • Extent of the disease:

    • Patients are required to have at least one measurable lesion.
    • Stage III or IV without evidence of distant metastases, according to the TNM staging system. Absence of metastases must be checked by chest X-ray (with or without Computed tomography (CT) ), abdominal ultrasound or CT in case of liver function test abnormalities, and bone scan in case of local symptoms.
    • Tumor considered as inoperable after evaluation by a multidisciplinary team. Reason for inoperability will be reported in the CRF
  • World Health Organization (WHO) performance status 0 or 1
  • Laboratory data:

    • Haematology:
  • Neutrophil count > or = 2.0*10^9/L
  • Platelet count > or = 100*10^9/L
  • Hemoglobin > or = 10 g/dl (6.2 mmol/L)

    • Hepatic function:
  • Total serum bilirubin < or = 1 time the upper normal limit (UNL) of the participating center
  • Aspartate transaminase (ASAT/SGOT) and Alanine transaminase (ALAT/SGPT) < or = 2.5UNL
  • Alkaline phosphatase < or = 5 UNL
  • Patients with ASAT or ALAT > 1.5UNL associated with alkaline phosphatase >2.5UNL are not eligible for the study

    • Renal function:
  • serum creatinine < or = 120µmol/L (1.4 mg/dl) if values are >120µmol/L, creatinine clearance should be > or = 60 ml/min
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule, those conditions should be discussed with the patient before registration in the trial
  • Patients informed consent form obtained

Exclusion criteria:

  • Tumors of the nasopharynx, the nasal and paranasal cavities.
  • Previous chemotherapy or radiotherapy for any reason and previous surgery for SCCHN at time of study entry.
  • Prior treatment within a therapeutic clinical tria within 30 days prior to study entry
  • Concurrent treatment with any other anticancer therapy
  • Chronic treatment (> or = 3 months) with corticosteroids at a daily dose > or = 20mg methylprednisolone or equivalent.
  • Concomitant use of drugs which could interact with 5-fluorouracil (e.g. cimetidine, allopurinol, folic or folinic acid, methotrexate and metronidazole)
  • Previous or current malignancies at other sites with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years
  • Symptomatic peripheral neuropathy > or = grade 2 by NCIC-CTG criteria
  • Clinical altered hearing
  • Pregnant, lactating women or of childbearing potential unless adequate
  • with other serious illness or medical condition including but not limited to:

    • unstable cardiac disease despite treatment
    • myocardial infarction within 6 months prior to study entry
    • history of significant neurologic or psychiatric disorders including dementia or seizures
    • active uncontrolled infection
    • active peptic ulcer
    • chronic obstructive pulmonary disease requiring hospitalization during the year preceding study entry

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995293

Contacts
Contact: Trial Transparency Team Contact-us@sanofi.com

Locations
China
Sanofi Administrative Office Recruiting
Shanghai, China
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Mo Chen Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00995293     History of Changes
Other Study ID Numbers: DOCET_L_02557
Study First Received: September 22, 2009
Last Updated: January 31, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Carcinoma
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Docetaxel
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on April 22, 2014