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
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Head and Neck Cancer
Intervention: Oxaliplatin, 5-FU (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
Nathalie Billon, Study Director, Affiliation: Sanofi-Aventis
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)
Clinical Details
Official 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
Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: 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: To investigate the safety profile of this regimen in the above indication and consider other criteria of efficacy (clinical benefit, survival)
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
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:
-
Locations and Contacts
Sanofi-Aventis, Paris, France
Additional Information
clinicalstudyresults.org
Starting date: May 2000
Ending date: February 2003
Last updated: January 28, 2008
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