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Phase II Study of Oxaliplatin in Combination With 5-Fu in 1st Line Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck

NCT00611754 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2008-02-11

No results posted yet for this study

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)

Conditions

Interventions

DRUG

Oxaliplatin, 5-FU

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.

Sponsors & Collaborators

Principal Investigators

  • Nathalie Billon · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-05-31
Completion
2003-02-28

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00611754 on ClinicalTrials.gov