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

Phase 2

Completed

• Conditions: Head and Neck Cancer

• Registration Number: NCT00611754
• Lead Sponsor: Sanofi

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2000-05
• Study Completion: 2003-02
• Status Verified: 2008-01
• Study First Submitted: 2008-01-28
• Study First Submitted QC: 2008-01-28
• Last Update Submitted: 2008-01-28
• Study First Posted: 2008-02-11
• Last Update Posted: 2008-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Sanofi-Aventis; 🇫🇷 Paris, France