Official Title: “A Phase I/II Study of Taxotere, Cisplatin, 5-Fluorouracil and Leucovorin for Squamous Cell Carcinoma of the Head and Neck”

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.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2006

- 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 the taxotere is completed, the patient will receive a 4 hour infusion of cisplatin and begin a four day continuous infusion of 5-fluorouracil and leucovorin. The infusion of 5-fluorouracil and leucovorin will be completed at home with the use of an infusion pump. This process will be repeated every 21-35 days (1 cycle) depending upon how quickly the patient recovers from the chemotherapy. - During each cycle blood tests will be performed weekly. During the first cycle a physical exam will be performed weekly and then halfway through each subsequent cycle and immediately prior to the start of each subsequent cycle. - At the end of each cycle the impact of the chemotherapy will be assessed. If after 2 cycles the cancer has not responded the treatment will end.

If significant reduction in the size of the tumor is observed, a third and final cycle will be done. - After the last cycle of chemotherapy is done, radiation therapy will be performed twice daily for 6-7 weeks.

Intervention(s) in this Clinical Trial

• Drug: Taxotere
• Drug: Cisplatin
• Drug: 5-Fluorouracil
• Drug: Leucovorin

Primary Measures

• To determine the maximum tolerated dose of taxotere, cisplatin, 5-fluorouracil and leucovorin.

Secondary Measures

• To evaluate the side effects of a four day outpatient regimen with taxotere, cisplatin, 5-fluorouracil and leucovorin
• to obtain preliminary information about the effectiveness of the drug combination.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Dana-Farber Cancer Institute

Overall Clinical Trial Officials and Contacts

Marshall Posner, MD Principal Investigator Dana-Farber Cancer Institute  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00139243

Study ID Number: 97-130

ClinicalTrials.gov Identifier: NCT00139243

Health Authority: United States: Food and Drug Administration