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

Condition(s) targeted: Squamous Cell Carcinoma; Carcinoma of Head and/or Neck

Intervention: Taxotere (Drug); Cisplatin (Drug); 5-Fluorouracil (Drug); Leucovorin (Drug)

Phase: Phase 1/Phase 2

Status: Completed

Sponsored by: Dana-Farber Cancer Institute

Official(s) and/or principal investigator(s):
Marshall Posner, MD, Principal Investigator, Affiliation: Dana-Farber Cancer Institute

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.

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

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

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

Secondary outcome:

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.

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 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Dana-Farber Cancer Institute, Boston, Massachusetts 02115, United States

Massachusetts General Hospital, Boston, Massachusetts 02115, United States

Related publications:

Colevas AD, Norris CM, Tishler RB, Lamb CC, Fried MP, Goguen LA, Gopal HV, Costello R, Read R, Adak S, Posner MR. Phase I/II trial of outpatient docetaxel, cisplatin, 5-fluorouracil, leucovorin (opTPFL) as induction for squamous cell carcinoma of the head and neck (SCCHN). Am J Clin Oncol. 2002 Apr;25(2):153-9.

Haddad R, Colevas AD, Tishler R, Busse P, Goguen L, Sullivan C, Norris CM, Lake-Willcutt B, Case MA, Costello R, Posner M. Docetaxel, cisplatin, and 5-fluorouracil-based induction chemotherapy in patients with locally advanced squamous cell carcinoma of the head and neck: the Dana Farber Cancer Institute experience. Cancer. 2003 Jan 15;97(2):412-8.

Starting date: October 1997
Last updated: June 2, 2008