NCT00401323

Brief Summary

The purpose of the study is to compare time to progression and overall survival after treatment with Taxotere plus cisplatin versus cisplatin plus 5-FU (PF treatment group) in the first line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
568

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 1998

Longer than P75 for phase_2

Geographic Reach
19 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1998

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 20, 2006

Completed
Last Updated

January 20, 2011

Status Verified

January 1, 2011

Enrollment Period

5.4 years

First QC Date

November 17, 2006

Last Update Submit

January 19, 2011

Conditions

Head and Neck NeoplasmsNeoplasm Recurrence, LocalNeoplasm Metastasis

Outcome Measures

Primary Outcomes (1)

  • time to progression

    up to 5 years

Secondary Outcomes (1)

  • overall survival, overall response rate (complete response + partial response), duration of response, and time to treatment failure

    up to 5 years

Study Arms (3)

docetaxel plus cisplatin

EXPERIMENTAL

Taxotere 75 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by cisplatin 75 mg/m² administered as a 30-minute to 3-hour infusion on Day 1

Drug: docetaxel (XRP6976)Drug: cisplatin

cisplatin plus 5-FU

ACTIVE COMPARATOR

Cisplatin 100 mg/m², 30-minute to 3-hour infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 1000 mg/m²/day from Day 1 to Day 5

Drug: cisplatinDrug: 5-fluorouracil (5-FU)

docetaxel plus 5-FU

EXPERIMENTAL

Taxotere 85 mg/m², one-hour IV infusion on Day 1 of each 3-week cycle followed by the continuous infusion of 5-FU 750 mg/m²/day from Day 1 to Day 5 Arm only in the phase II part of the study

Drug: docetaxel (XRP6976)Drug: 5-fluorouracil (5-FU)

Interventions

docetaxel (XRP6976)DRUG
Also known as: Taxotere
docetaxel plus 5-FUdocetaxel plus cisplatin
cisplatinDRUG
cisplatin plus 5-FUdocetaxel plus cisplatin
5-fluorouracil (5-FU)DRUG
cisplatin plus 5-FUdocetaxel plus 5-FU

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologically or cytologically documented squamous cell carcinoma of the head and neck (SCCHN) (eligible primary sites: oral cavity, oropharynx, hypopharyx, or larynx) presenting with locally recurrent and/or metastatic disease, with at least 1 unidimensionally or bidimensionally measurable lesion.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

sanofi-aventis US

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis

Buenos Aires, Argentina

Location

sanofi-aventis, Australia

Macquarie Park, New South Wales, Australia

Location

Sanofi-Aventis

Vienna, Austria

Location

sanofi-aventis, Belgium

Diegem, Belgium

Location

Sanofi-Aventis

Rio de Janeiro, Brazil

Location

sanofi-aventis Canada

Laval, Quebec, Canada

Location

sanofi-aventis, France

Paris, France

Location

sanofi-aventis Germany

Berlin, Germany

Location

sanofi-aventis Greece

Athens, Greece

Location

Sanofi-Aventis

Basse-Terre, Guadeloupe

Location

Sanofi-Aventis Hungaria

Budapest, Hungary

Location

sanofi-aventis Israel

Netanya, Israel

Location

sanofi-aventis Italy

Milan, Italy

Location

Sanofi-Aventis

Saint-Denis, Reunion

Location

Sanofi-Aventis

Moscow, Russia

Location

sanofi-aventis South Africa

Midrand, South Africa

Location

Sanofi-Aventis

Madrid, Spain

Location

sanofi-aventis Switzerland

Geneva, Switzerland

Location

Sanofi-Aventis

Montevideo, Uruguay

Location

MeSH Terms

Conditions

Head and Neck NeoplasmsNeoplasm Recurrence, LocalNeoplasm Metastasis

Interventions

DocetaxelCisplatinFluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 17, 2006

First Posted

November 20, 2006

Study Start

January 1, 1998

Primary Completion

June 1, 2003

Study Completion

June 1, 2003

Last Updated

January 20, 2011

Record last verified: 2011-01

Locations

AU(1)BR(1)CA(1)AR(1)IL(1)DE(1)GR(1)BE(1)RU(1)FR(1)IT(1)UR(1)RE(1)ZA(1)HU(1)GU(1)ES(1)US(1)CH(1)