Study of Taxotere, Cisplatin, 5-Fluorouracil, and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
Completed · Phase 1/Phase 2
Conditions studied: Squamous Cell Carcinoma, Carcinoma of Head and/or Neck
In brief
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 combination is effective in treating squamous cell carcinoma of the head and neck.
Key facts
- Study ID
- NCT00139243
- Run by
- Dana-Farber Cancer Institute
- People needed
- 30
- Starts
- 1997-10-01
- Expected to finish
- 2006-01-01
- Last updated by the study team
- 2008-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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