Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139243
Status:
COMPLETED
Last Update Posted:
2008-06-04
First Post:
2005-08-29
Brief Title:
Study of Taxotere Cisplatin 5-Fluorouracil and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
A Phase III Study of Taxotere Cisplatin 5-Fluorouracil and Leucovorin for Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 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