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
  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:


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
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: 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 by Sanofi

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 July 26, 2014