Text Size

Docetaxel in Head and Neck Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00261703
First received: December 2, 2005
Last updated: May 10, 2012
Last verified: May 2012
History of Changes
  Purpose

Primary Objective:

  • Phase II: To determine the best treatment scheme (TPF vs. PF).
  • Phase III: To compare the time to progression and the treatment failure at the 3 arms.

Secondary objectives:

  • To evaluate the safety at the 3 arms.
  • To compare the progression , overall survival and locoregional control at the 3 arms.

Condition Intervention Phase
Head and Neck Neoplasms
 Drug: Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy
Drug: Cisplatin, 5-fluorouracil (5-FU), radiotherapy
Other: Cisplatin + radiotherapy
 Phase 2
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: Randomized Phase III Trial Comparing Induction Chemotherapy With Cisplatin/5-fluorouracil (PF) or Docetaxel/Cisplatin/5-fluorouracil (TPF) Plus Chemoradiotherapy (CRT) Versus CRT Alone as First-line Treatment or Unresectable Locally Advanced Head and Neck Cancer (LAHNC).

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Phase II: Clinical objective response rate, at the end of inducted chemotherapy (groups A and B) and at the end of combined treatment (groups A, B and C). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
  • Phase III: Surveillance with no progression after two years. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 439
Study Start Date: December 2002
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
(Docetaxel + Cisplatin + 5-FU) + Cisplatin + Radiotherapy
 Drug: Docetaxel, Cisplatin, 5-fluorouracil (5-FU), radiotherapy
Docetaxel 75 mg/m2, Day 1 of the cycle + Cisplatin 75 mg/m2 Day 1 + 5-FU 750 mg/m2/day in 24-h continuous infusion for 5 days. 3 cycles will be administered, every 21 days, before the local-regional treatment (same as control group)
Experimental: 2
(Cisplatin + 5-FU) + Cisplatin + Radiotherapy
 Drug: Cisplatin, 5-fluorouracil (5-FU), radiotherapy
Cisplatin 100 mg/m2 Day 1, 5-FU 1000 mg/m2/day in 24-h continuous infusion for 5 consecutive days. 3 cycles will be administered every 21 days, before the local-regional treatment (same as control group)
Experimental: 3
Cisplatin + Radiotherapy
 Other: Cisplatin + radiotherapy
Cisplatin 100 mg/m2 on days 1, 22 and 43 simultaneously with radiotherapy (2 Gy x 1/day, 5 days per week for 7 weeks-tumor- and 2 Gy x 1/day, 5 days per week for 6 weeks- lymph nodes)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Head and Neck cancer locally advanced (oral cavity, oropharynx, hypopharynx or larynx) but without evident metastasis.
  • Inoperable tumor after revision by a multidisciplinary oncology team.
  • Proved epidermoid carcinoma.
  • ECOG = 0-1
  • Good hematologic function (i.e, hemoglobin > 10 g/dl, ...)
  • Good hepatologic function
  • Good renal function

Exclusion Criteria:

  • Pregnant or breast-feeding women. Potential child-bearing women should use an effective conceptive method and should have a negative pregnancy test at least the week before entering the study.
  • Nasopharynx, nasal cavity and paranasal sinusitis will be excluded
  • Previous chemotherapeutic or radiotherapeutic treatment for this disease.
  • Previous or current neoplasms in other locations, except in situ cervicouterine cancer properly treated or basal cell or squamous cell carcinoma
  • Symptomatic peripheral neuropathy
  • Other clinical severe diseases
  • Concomitant treatment with corticoids within 6 months prior to inclusion.
  • Concomitant treatment with any other neoplastic therapy
  • Previous treatment for current disease.
  • Loss of weight greater than 10% within the last 3 months.

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: NCT00261703

Locations
Portugal
Sanofi-Aventis
Porto Salvo, Portugal
Spain
Sanofi-Aventis
Barcelona, Spain
Sponsors and Collaborators
Sanofi
Investigators
Study Director: JOSÉ Mª TABOADA Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00261703     History of Changes
Other Study ID Numbers: XRP6976F_2503
Study First Received: December 2, 2005
Last Updated: May 10, 2012
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Neoplasms
Head and Neck Neoplasms
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 May 16, 2013