Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139230
Status:
COMPLETED
Last Update Posted:
2008-06-03
First Post:
2005-08-29
Brief Title:
Combination Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
TPLF-4 Compressed TPLF for Locally Advanced Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 patients ANC level is greater than 10000
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
Approximately 6-12 hours after the chemotherapy ends patients will be given growth factor support and ciprofloxacin until the patients ANC level is greater than 10000
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None