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

Phase 1

Completed

• Conditions: Squamous Cell Carcinoma; Carcinoma of Head and/or Neck

• Registration Number: NCT00139243
• Lead Sponsor: Dana-Farber Cancer Institute

Brief 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.

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.

Study Timeline

• Study Start: 1997-10
• Study First Submitted: 2005-08-29
• Study First Submitted QC: 2005-08-29
• Study First Posted: 2005-08-31
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Status Verified: 2008-06
• Last Update Submitted: 2008-06-02
• Last Update Posted: 2008-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States