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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
ClinicalTrials.gov processed this data on August 20, 2015
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

Official(s) and/or principal investigator(s):
Nathalie Billon, Study Director, Affiliation: Sanofi

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

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

Starting date: May 2000
Last updated: January 28, 2008

Page last updated: August 20, 2015

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