Status:
COMPLETED
Study of Taxotere, Cisplatin, 5-Fluorouracil, and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Sanofi
Brigham and Women's Hospital
Conditions:
Squamous Cell Carcinoma
Carcinoma of Head and/or Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine the safety and maximum tolerated dose of the combination taxotere, cisplatin, 5-fluorouracil and leucovorin. We will also preliminarily assess whether the com...
Detailed Description
* Patients will be premedicated at home with dexamethasone and leucovorin. * On the first day of treatment, the patient will receive taxotere intravenously for one hour. Approximately one hour after t...
Eligibility Criteria
Inclusion
- Histologic documentation of squamous cell carcinoma of head and neck
- Patients will previously untreated stage III or IV squamous cell carcinoma.
- Patients with locally recurrent disease after surgery.
- Life expectancy of longer than 3 months.
- Kidney function: 1.5 or a 24 hour creatinine clearance of \> 30ml/min
- Liver function: SGOT \< 1.5 X upper normal limit and alkaline phosphatase of \< 2.5 X upper normal limit.
- WBC greater than or equal to 4,000/mm
- Platelet count greater than or equal to 100,000/mm
- Hemoglobin greater than or equal to 10gm/dl
- Patients of child-bearing age must use effective methods of contraception.
Exclusion
- Patients treated with previous chemotherapy or radiotherapy for head and neck cancer.
- Patients with concurrent malignancy of any site except limited basal cell carcinoma, squamous carcinoma of the skin or carcinoma in situ of the cervix.
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
October 1 1997
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00139243
Start Date
October 1 1997
End Date
January 1 2006
Last Update
June 4 2008
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115