Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459043
Status:
COMPLETED
Last Update Posted:
2013-07-03
First Post:
2007-04-10
Brief Title:
Docetaxel in Combination With Zactima ZD6474 in Patients With Locally Advanced Squamous Cell Carcinoma of the the Head and Neck
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Randomized Phase II Study of Docetaxel in Combination With Zactima ZD6474 in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2013-07
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:
In this research study the researchers are comparing the combination of docetaxel and Zactima with docetaxel alone to see if the combination of the two drugs will be more effective than docetaxel alone Zactima blocks the actions of three substances in the body 1vascular endothelial growth factor reception VEGFR 2epidermal growth factor receptor EGFR and 3 rearranged during transfection RET VEGFR stimulates the growth of new blood vessels When certain proteins bind to the VEGF receptor a process begins to occur which allows new blood vessels to be made that provide blood to the cancer cells Zactima is thought to block these proteins from binding to the VEGF receptor which would then block the process that creates new blood vessels EGFR controls how quickly cells grow and multiply RET is thought to have a particularly significant role in the development and growth of squamous cell tumors The actions of Zactima are very different from the way standard chemotherapy drugs work Researchers believe that Zactima might have different side effects from other cancer treatments so another one of the purposes of this study is to assess the side effects caused by the drug
Detailed Description:
Participants will be randomized into one of the following study groups Docetaxel or Docetaxel with Zactima Randomization means that participants will be put into a group by chance
The Docetaxel group will receive docetaxel on the first day of every treatment cycle which lasts for 3 weeks Even though treatment will occur once every three weeks participants will return to the clinic on a weekly basis for the first two cycles After the first two cycles they will only have to return to the clinic at the start of each cycle
The combination Docetaxel and Zactima group will also receive docetaxel once every three weeks In addition to the docetaxel they will also take a Zactima pill orally every morning They will also have to return to the clinic on a weekly basis just as those in the docetaxel only group
The following tests and procedures will be performed during each cycle of treatment regardless of which group the participant is randomized into These are considered standard of care for treating patients with chemotherapy for recurrent head and neck cancer physical exams blood tests urine test nasopharyngoscopy repeat imaging of the tumor x-ray CT MRI or PET photographs of the tumor In addition to the tests mentioned above the Zactima group will have EKGs performed 3 times on the first day of treatment once at week 2 then at the beginning of cycles 2 and 3 and then every 6 weeks
Participants will continue on the study as long as they are receiving benefit and are not experiencing any unmanageable side effects
The Docetaxel group will receive docetaxel on the first day of every treatment cycle which lasts for 3 weeks Even though treatment will occur once every three weeks participants will return to the clinic on a weekly basis for the first two cycles After the first two cycles they will only have to return to the clinic at the start of each cycle
The combination Docetaxel and Zactima group will also receive docetaxel once every three weeks In addition to the docetaxel they will also take a Zactima pill orally every morning They will also have to return to the clinic on a weekly basis just as those in the docetaxel only group
The following tests and procedures will be performed during each cycle of treatment regardless of which group the participant is randomized into These are considered standard of care for treating patients with chemotherapy for recurrent head and neck cancer physical exams blood tests urine test nasopharyngoscopy repeat imaging of the tumor x-ray CT MRI or PET photographs of the tumor In addition to the tests mentioned above the Zactima group will have EKGs performed 3 times on the first day of treatment once at week 2 then at the beginning of cycles 2 and 3 and then every 6 weeks
Participants will continue on the study as long as they are receiving benefit and are not experiencing any unmanageable side effects
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