Study of Taxotere, Cisplatin, 5-Fluorouracil, and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
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.
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 Design
Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Squamous Cell Carcinoma
Intervention
Taxotere, Cisplatin, 5-Fluorouracil, Leucovorin
Location
Dana-Farber Cancer Institute
Boston
Massachusetts
United States
02115
Status
Completed
Source
Dana-Farber Cancer Institute
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00139243
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Carcinoma, Squamous Cell
A carcinoma derived from stratified squamous epithelium. It may also occur in sites where glandular or columnar epithelium is normally present. (From Stedman, 25th ed)
Carcinoma, Non-small-cell Lung
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.
Carcinoma, Adenosquamous
A mixed adenocarcinoma and squamous cell or epidermoid carcinoma.
Granular Cell Tumor
Unusual tumor affecting any site of the body, but most often encountered in the head and neck. Considerable debate has surrounded the histogenesis of this neoplasm; however, it is considered to be a myoblastoma of, usually, a benign nature. It affects women more often than men. When it develops beneath the epidermis or mucous membrane, it can lead to proliferation of the squamous cells and mimic squamous cell carcinoma.
Cisplatin
An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.
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