Ignite Creation Date:
2024-05-05 @ 5:09 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00392665
Status:
TERMINATED
Last Update Posted:
2017-04-13
First Post:
2006-10-24
Brief Title:
BevacizumabTarceva and TarcevaSulindac in Squamous Cell Carcinoma of the Head and Neck
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Randomized Study of BevacizumabTarceva and TarcevaSulindac in Squamous Cell Carcinoma of the Head and Neck
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this research study is to collect information to learn how effective erlotinib tarceva is in combination with either bevacizumab or sulindac in treating patients with squamous cell carcinoma of the head and neck Erlotinib and bevacizumab are targeted therapy drugs that can control tumor growth by targeting specific abnormalities sometimes found on cancer cells Erlotinib targets epidermal growth factor receptor EGFR and bevacizumab targets vascular endothelial growth factor VEGF Sulindac is a non-steroidal anti-inflammatory drug NSAID that can block G protein-coupled receptor which laboratory evidence shows is associated with both cancer cell growth and EGFR activity The bevacizumab being administered in this study is not a commercially marketed formulation of the drug Previous research with head and neck cancer suggest that erlotinib alone has some anti-cancer activity This research study is designed to see how well erlotinib works in combination with bevacizumab or sulindac in head and neck cancer
Detailed Description:
Participants will be randomized to either Arm A erlotinib plus bevacizumab or Arm B erlotinib plus sulindac Participants will have an equal chance of being placed in any group
Medication on Arm A erlotinib plus bevacizumab Participants will take erlotinib pills orally once a day Bevacizumab will be given intravenously on day one of each treatment cycle each treatment cycle will last three weeks Urine tests will be performed once every three weeks to test kidney function
Medication on Arm B erlotinib plus sulindac Participants will take erlotinib pills orally once a day Sulindac will be taken orally twice a day
Physical exams will be performed during each treatment cycle and will include vital signs and general health questions We will take the participants blood pressure every 2 weeks for the first 6 weeks After that point we will take it every 3 weeks or more often if necessary Blood tests will be performed including chemistry and hematology
After every 2 cycles a repeat CT scan MRI andor PET scan will be performed along with either a chest x-ray or CT scan to ensure that there is no tumor in the participants lungs We may also do a bone scan if there may be tumor in the participants bones and abdominal CT scan if there may be tumor in the liver and a head CT scan or MRI if there may be tumor in the brain
After the final treatment the participant will be seen in the clinic to see if they have had any side effects from the drugs within 30 days of stopping the drugs
Participants will be in this research study for as long as they are receiving clinical benefits from the study drugs and do not develop excessive side effects or disease progression After treatment is discontinued we will follow the participant closely for 30 days and every 1-2 months after that
Medication on Arm A erlotinib plus bevacizumab Participants will take erlotinib pills orally once a day Bevacizumab will be given intravenously on day one of each treatment cycle each treatment cycle will last three weeks Urine tests will be performed once every three weeks to test kidney function
Medication on Arm B erlotinib plus sulindac Participants will take erlotinib pills orally once a day Sulindac will be taken orally twice a day
Physical exams will be performed during each treatment cycle and will include vital signs and general health questions We will take the participants blood pressure every 2 weeks for the first 6 weeks After that point we will take it every 3 weeks or more often if necessary Blood tests will be performed including chemistry and hematology
After every 2 cycles a repeat CT scan MRI andor PET scan will be performed along with either a chest x-ray or CT scan to ensure that there is no tumor in the participants lungs We may also do a bone scan if there may be tumor in the participants bones and abdominal CT scan if there may be tumor in the liver and a head CT scan or MRI if there may be tumor in the brain
After the final treatment the participant will be seen in the clinic to see if they have had any side effects from the drugs within 30 days of stopping the drugs
Participants will be in this research study for as long as they are receiving clinical benefits from the study drugs and do not develop excessive side effects or disease progression After treatment is discontinued we will follow the participant closely for 30 days and every 1-2 months after that
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