Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00513383
Status:
COMPLETED
Last Update Posted:
2017-03-01
First Post:
2007-08-07
Brief Title:
Panitumumab Chemoradiotherapy Chemotherapy for Squamous Cancer of the Head and Neck
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Phase I Study Panitumumab Plus Chemoradiotherapy and Induction Chemotherapy in Patients With Locally Advanced Squamous Cell Cancer of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2017-02
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:
This study is being done to test whether panitumumab in combination with chemotherapy and radiation is safe in people with head and neck cancer Another goal of this study is to find the highest dose of the study drugs that can be given safely without causing serious sife effects Panitumumab is a type of drug called a monoclonal antibody that has been studied in other types of cancers such as kidney and colon This monoclonal antibody is directed against the epidermal growth factor receptor EGFR EGFR has been found on the majority of head and neck cancer cells By blocking EGFR this monoclonal antibody may inhibit the growth of head and neck cancer cells
Detailed Description:
There are two parts to this study Part A and Part B Participants enrolled in Part A of this study received panitumumab and chemoradiotherapy Participants enrolled in Part B will receive panitumumab in combination with induction chemotherapy followed by chemoradiotherapy
The main purpose of Part A was to examine the safety and the best dosing of panitumumab chemotherapy and radiation for the treatment of head and neck cancer The best dosing was determined by increasing doses of chemotherapy given in combination with panitumumab during radiation The chemotherapy drugs being used in Part A were carboplatin and paclitaxel which are standard therapies used in head and neck cancer These drugs were be added to radiation and this combination is called chemoradiotherapy The investigators have determined the best dose of panitumumab and chemotherapy to give with radiation Part B has now begun
The main purpose of Part B is to examine the safety and best dosing of chemotherapy combined with panitumumab called induction therapy prior to receiving panitumumab and chemoradiotherapy The drugs that are used for induction chemotherapy will be docetaxel cisplatin and 5-fluorouracil These drugs are also standard therapies used in head and neck cancer
The main purpose of Part A was to examine the safety and the best dosing of panitumumab chemotherapy and radiation for the treatment of head and neck cancer The best dosing was determined by increasing doses of chemotherapy given in combination with panitumumab during radiation The chemotherapy drugs being used in Part A were carboplatin and paclitaxel which are standard therapies used in head and neck cancer These drugs were be added to radiation and this combination is called chemoradiotherapy The investigators have determined the best dose of panitumumab and chemotherapy to give with radiation Part B has now begun
The main purpose of Part B is to examine the safety and best dosing of chemotherapy combined with panitumumab called induction therapy prior to receiving panitumumab and chemoradiotherapy The drugs that are used for induction chemotherapy will be docetaxel cisplatin and 5-fluorouracil These drugs are also standard therapies used in head and neck cancer
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