Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343083
Status:
COMPLETED
Last Update Posted:
2019-08-19
First Post:
2006-06-20
Brief Title:
Evaluation of Cetuximab ERBITUX and Concurrent Carboplatin Paclitaxel Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck GCC 0442
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Phase II Study of Evaluation of Cetuximab ERBITUX and Concurrent Carboplatin Paclitaxel Radiotherapy in the Management of Patients With Advanced Locoregional Squamous Cell Carcinomas of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2019-08
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:
The purpose of this study is to evaluate the response of the tumor to the treatment regimen that will be used in this study This study will also test the safety of cetuximab C225 given with chemotherapy and radiation therapy We also want to see what effects good and bad cetuximab chemotherapy and radiation therapy have head neck cancer
C225 has been designed to stop the growth of the tumor by blocking certain chemical pathways that lead to tumor cell growth In prior studies with head neck cancer patients C225 has delayed tumor growth and provided relief of symptoms in some patients
C225 has been designed to stop the growth of the tumor by blocking certain chemical pathways that lead to tumor cell growth In prior studies with head neck cancer patients C225 has delayed tumor growth and provided relief of symptoms in some patients
Detailed Description:
Primary Objective- To evaluate whether the addition of Cetuximab C225 in combination with chemotherapy and radiation can cause an enhanced anti-tumor effect resulting in improving local regional control of patients with locally advanced unresectable squamous cell carcinoma of head and neck SCCHN
OVERVIEW OF STUDY DESIGN Open label non-randomized single arm trial
P Paclitaxel will be administered on a weekly schedule at a dose of 40mgm2 IV by 1-hour infusion prior to cetuximab dose This will be administered for a total of 8 weeks from weeks 2-9
C225 Cetuximab 400 mgm2 IV will be given as the initial OR loading dose in week 1 and then 250 mgm2 IV weekly will be given for 8 weeks weeks 2-9
C Carboplatin will be given at a dose of AUC2week - will be administered as a 30 minute infusion after cetuximab infusion weeks 2-9
RT Radiation therapy will be delivered at 18 Gy fractionday 5 days a week for a total of 702 Gy RT will be given from weeks 2-9
Note Sequence of administration will be paclitaxel followed by cetuximab followed by carboplatin followed by XRT
Approximately 60 patients from MSGCCBVAMC will participate in this study Prior to entering the study the doctor will examine the patient and order blood tests which will be done by blood draw approximately 2 tablespoons and tests to measure the patients disease scans The patient will also be evaluated by a dietician who will follow the patient throughout the course of the therapy to help the patient meet hisher nutritional needs
OVERVIEW OF STUDY DESIGN Open label non-randomized single arm trial
P Paclitaxel will be administered on a weekly schedule at a dose of 40mgm2 IV by 1-hour infusion prior to cetuximab dose This will be administered for a total of 8 weeks from weeks 2-9
C225 Cetuximab 400 mgm2 IV will be given as the initial OR loading dose in week 1 and then 250 mgm2 IV weekly will be given for 8 weeks weeks 2-9
C Carboplatin will be given at a dose of AUC2week - will be administered as a 30 minute infusion after cetuximab infusion weeks 2-9
RT Radiation therapy will be delivered at 18 Gy fractionday 5 days a week for a total of 702 Gy RT will be given from weeks 2-9
Note Sequence of administration will be paclitaxel followed by cetuximab followed by carboplatin followed by XRT
Approximately 60 patients from MSGCCBVAMC will participate in this study Prior to entering the study the doctor will examine the patient and order blood tests which will be done by blood draw approximately 2 tablespoons and tests to measure the patients disease scans The patient will also be evaluated by a dietician who will follow the patient throughout the course of the therapy to help the patient meet hisher nutritional needs
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CA225092 | None | None | None |