NCT00611754

Brief Summary

To evaluate the efficacy of first line oxaliplatin in combination with 5-fluorouracil (5-FU) in patients with advanced inoperable or metastatic head and neck cancer and to investigate the safety profile of this regimen in the above indication and consider other criteria of efficacy (clinical benefit, survival)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_2 head-and-neck-cancer

Timeline
Completed

Started May 2000

Shorter than P25 for phase_2 head-and-neck-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2000

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2003

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

January 28, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
Last Updated

February 11, 2008

Status Verified

January 1, 2008

First QC Date

January 28, 2008

Last Update Submit

January 28, 2008

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

  • To evaluate the efficacy of first line oxaliplatin in combination with 5-fluorouracil (5-FU) in patients with advanced inoperable or metastatic head and neck cancer.

Secondary Outcomes (1)

  • To investigate the safety profile of this regimen in the above indication and consider other criteria of efficacy (clinical benefit, survival)

Interventions

Oxaliplatin, 5-FUDRUG

Oxaliplatin: 130 mg/m² in 500 mL of 5% glucose solution as a 2-hour intravenous (IV) infusion on Day 1 and repeated every 3 weeks; 5-FU: following oxaliplatin administration, 1000 mg/m²/day as a continuous IV infusion from Day 1 toDay 4, every 3 weeks.Dose adjustments were made if the patient experienced AEs.

Also known as: Eloxatin®, Fluorouracil

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Paris, France

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

OxaliplatinFluorouracil

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Nathalie Billon

    Sanofi

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

January 28, 2008

First Posted

February 11, 2008

Study Start

May 1, 2000

Study Completion

February 1, 2003

Last Updated

February 11, 2008

Record last verified: 2008-01

Locations

FR(1)