Combination Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
The purpose of this study is to further test a combination chemotherapy regimen for the treatment of squamous cell carcinoma of the head and neck and to see if the addition of supportive medicine can help reduce the side effects of these drugs.
- Patients will be admitted to hospital and receive a one hour infusion of taxotere. Approximately 2 hours after taxotere is finished they will receive cisplatin, 5-fluorouracil, and leucovorin continuously over a 4 day period.
- Approximately 6-12 hours after the chemotherapy ends patients will be given growth factor support and ciprofloxacin until the patient's ANC level is greater than 10,000.
- Infusion of chemotherapy will be repeated every 28 days (1 cycle is 28 days).
- During each cycle patients will have blood tests performed weekly and may be asked to return to the Head and Neck Clinic for examination around the middle of each cycle.
- At the end of each cycle the impact of the chemotherapy will be assessed. If after 2 cycles, the cancer has not responded sufficiently the patient will not receive any more chemotherapy. However, if significant reduction in the size of the patients tumor is observed, a third and final cycle will be performed.
- During the fourth or fifth week of cycle 3, patients will undergo re-staging evaluation under anesthesia with primary-site biopsies and planning of radiotherapy.
- Within 2 weeks of completion of chemotherapy cycle 3 all patients will receive twice daily radiotherapy.
Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Squamous Cell Carcinoma
Taxotere, Cisplatin, 5-Fluorouracil, Leucovorin, G-CSF, Ciprofloxacin
Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00139230
- 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.
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.
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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