Skip to main content
OpenTrials
Completed

NCT Number: NCT00611754

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sanofi-Aventis

Paris, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients aged 18-70 years, with inoperable locally advanced or metastatic squamous cell carcinoma of the head and neck (stage III-IV) histologically proven, no prior chemo and/or hormone therapy for metastatic disease or local recurrence (adjuvant or neo-adjuvant chemotherapy or radio-chemotherapy was allowed if finished since more than 6 months before inclusion and cisplatinum total dose used < or=to 300 mg/m² or carboplatinum total dose used < or=to 200mg/m²), at least 1 target lesion (measurable in 2 dimensions > or=to 20 mm on computed tomography (CT) or magnetic resonance imaging (MRI) evaluated < 15 days before start of study treatment, outside of irradiated fields),performance status (PS) < or =to 2 World Health Organization (WHO), weight loss < 5% normal weight,hemoglobin > or =to 10 g/dL, neutrophils > or =to 2000/mm3, platelets > or =to 100,000/mm3 , creatinine < or =to 1.5 x upper limit of normal (ULN), bilirubin < or =to .5 x ULN, alanine amino-transferase (ALT)/aspartate amino-transferase (AST)< or =to 2.5 x ULN (5 x ULN if liver metastases), clotting: prothrombin time (PT) > or =to 60%. Written informed consent signed by patient and doctor prior to all study procedures -

Exclusion criteria

-

Treatment and study plan

Oxaliplatin, 5-FU

Drug

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.

Other names: Eloxatin®, Fluorouracil

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)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
2000
Study completion
2003
First posted
Feb 11, 2008
Registry last updated
Feb 11, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.