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

Phase 1/Phase 2
18 Years
Not Enrolling
Squamous Cell Carcinoma, Carcinoma of Head and/or Neck

Thank you

Trial Information

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

- 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

- 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.

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

Type of Study:


Study Design:

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

Outcome Measure:

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

Principal Investigator

Marshall Posner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

October 1997

Completion Date:

January 2006

Related Keywords:

  • Squamous Cell Carcinoma
  • Carcinoma of Head and/or Neck
  • squamous cell carcinoma
  • Taxotere
  • carcinoma of head/neck
  • Cisplatin
  • 5-Fluorouracil
  • Leucovorin
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617