Docetaxel in Head and Neck Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00261703
Recruitment Status : Completed
First Posted : December 5, 2005
Last Update Posted : May 11, 2012
Information provided by (Responsible Party):

Brief Summary:

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 or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 439 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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).
Study Start Date : December 2002
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. 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 ]
  2. Phase III: Surveillance with no progression after two years. [ Time Frame: 2 years ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00261703

Porto Salvo, Portugal
Barcelona, Spain
Sponsors and Collaborators
Study Director: JOSÉ Mª TABOADA Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi Identifier: NCT00261703     History of Changes
Other Study ID Numbers: XRP6976F_2503
First Posted: December 5, 2005    Key Record Dates
Last Update Posted: May 11, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs