NCT00139243

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Squamous Cell Carcinoma
• Carcinoma of Head and/or Neck

Interventions

Type	Name	Description
DRUG	Taxotere
DRUG	Cisplatin
DRUG	5-Fluorouracil
DRUG	Leucovorin

Timeline

• Start date: 1997-10-01
• Primary completion: 2006-01-01
• Completion: 2006-01-01
• First posted: 2005-08-31
• Last updated: 2008-06-04

Locations

2 sites across 1 country: United States