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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


Phase 2
18 Years
70 Years
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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


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:

-

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Safety Issue:

No

Principal Investigator

Nathalie Billon

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

EFC_7276

NCT ID:

NCT00611754

Start Date:

May 2000

Completion Date:

February 2003

Related Keywords:

  • Head and Neck Cancer
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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