This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Patients will receive chemotherapy using the drug Paclitaxel (Taxol) once a week for 3 weeks. The first dose is scheduled to be given about 2 weeks after surgery. Paclitaxel will be injected into a vein in the arm and will take about one hour to administer. This procedure will be given on an outpatient basis unless they are still in the hospital. After completion of the above treatment (approximately 5 weeks after surgery), they will receive radiation treatments once a day, 5 days a week for 5 1/2 to 7 weeks depending on the cancer. Treatments will be aimed at the prior location of the tumor on the head and neck. All radiation treatments will be given as an outpatient. Starting the third week of radiotherapy, they will receive the chemotherapy drugs Paclitaxel and Cisplatin, once a week until the end of radiation. These will be injected into a vein in the arm over a period of 4-5 hours. The chemotherapy treatments will be given on an outpatient basis. During the study, patients will have weekly physical exams, medical histories, blood tests (approximately 2 tablespoons) to assess cell counts and kidney/liver function, and any or all of the following (based on status of patient): chest x-ray, CT/MRI scan of the neck, CT scan of chest and/or abdomen, bone scan, dental evaluation or nutritional evaluation may be performed if necessary to check for side effects or the cancer. Follow-up for patients on this study involves: exam and biopsy under anesthesia to confirm recurrence, complete head and neck clinical exams by the head and neck surgeon and/or radiation oncologist every 3 months from end of treatment for 2 years, then every 6 months for 3 years, then anually. Patients should have a 'baseline' CT or MRI at 8-10 weeks after completion of all therapy and then only as clinically indicated, chest x-ray every 6 months and blood tests and other scans or x-rays as deemed clinically indicated. Patients are followed for life regarding several status on an annual basis.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR005096-17
Application #
7376264
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
17
Fiscal Year
2006
Total Cost
$583
Indirect Cost
Name
Tulane University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
053785812
City
New Orleans
State
LA
Country
United States
Zip Code
70118
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