Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139269
Status:
COMPLETED
Last Update Posted:
2008-06-04
First Post:
2005-08-29
Brief Title:
Study of Docetaxel in Combination With Cisplatin and 5-Fluorouracil in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Phase III Pilot Study of Induction Chemotherapy With Docetaxel in Combination With Cisplatin and 5-Fluorouracil 5-FU in Locally Advanced Squamous Cell Carcinoma of the Head and Neck SCCHN
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 appropriate dose that dose which is found to give maximum effect with limited toxicity of cisplatin in combination with docetaxel and 5-fluorouracil and then to further define the safety and effectiveness of this combination of medications
Detailed Description:
Treatment begins with a one hour infusion of docetaxel followed by a 12 hour infusion of cisplatin 5-fluorouracil will be administered through continuous IV infusion through a portable pump for four days at home A cycle is twenty-one days long 4 days of chemotherapy and 17 days of recovery
During each cycle blood tests will be performed weekly A physical exam will be performed and the impact of the chemotherapy will be assessed at the end of each cycle
If after 2 cycles the patients cancer has not responded sufficiently they will be removed from the study
If significant reduction in the size of the tumor is observed after cycle 2 a third and final cycle will be performed Followed by radiation therapy twice daily for approximately 6-7 weeks
During each cycle blood tests will be performed weekly A physical exam will be performed and the impact of the chemotherapy will be assessed at the end of each cycle
If after 2 cycles the patients cancer has not responded sufficiently they will be removed from the study
If significant reduction in the size of the tumor is observed after cycle 2 a third and final cycle will be performed Followed by radiation therapy twice daily for approximately 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