Study of Taxotere, Cisplatin, 5-Fluorouracil, and Leucovorin for Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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 combination is effective in treating squamous cell carcinoma of the head and neck.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Beth Israel Deaconess Medical Center; Brigham and Women's Hospital; Massachusetts General Hospital; Sanofi
• Treatments: Cisplatin; Docetaxel; Fluorouracil; Leucovorin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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