Status:
COMPLETED
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
Lead Sponsor:
Sanofi
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 profi...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2003
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00611754
Start Date
May 1 2000
End Date
February 1 2003
Last Update
February 11 2008
Active Locations (1)
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1
Sanofi-Aventis
Paris, France