Ignite Creation Date:
2024-05-05 @ 4:36 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00270790
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2005-12-23
Brief Title:
EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN TAXOL RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCERGCC 0202
Sponsor:
Mohan Suntharalingam
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A SINGLE SITE EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CONCURRENT CARBOPLATIN TAXOL RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH ADVANCED LOCOREGIONAL SQUAMOUS CELL CARCINOMAS OF THE HEAD AND NECK
Status:
COMPLETED
Status Verified Date:
2016-12
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:
Purpose of this study
There is some evidence that the best treatment for head and neck cancer involves a combination of radiation therapy and chemotherapy Radiation therapy is a form of cancer treatment using high energy x-rays Chemotherapy is a form of cancer treatment that uses special medications This study uses two chemotherapy drugs Taxol and Carboplatin which are FDA approved for treating head and neck cancers This treatment combination has been associated with difficulty pain or a burning sensation upon swallowing called esophagitis and decrease in blood cells cells in the blood which fight against infection The purpose of this study is to investigate whether the addition of another drug Amifostine can reduce the side effects of current combination treatment radiation and chemotherapy which is standard of care The addition of Amifostine is the investigational part of the study The research study is also looking at the side effects of Amifostine and cancers growth response to this combination treatment
There is some evidence that the best treatment for head and neck cancer involves a combination of radiation therapy and chemotherapy Radiation therapy is a form of cancer treatment using high energy x-rays Chemotherapy is a form of cancer treatment that uses special medications This study uses two chemotherapy drugs Taxol and Carboplatin which are FDA approved for treating head and neck cancers This treatment combination has been associated with difficulty pain or a burning sensation upon swallowing called esophagitis and decrease in blood cells cells in the blood which fight against infection The purpose of this study is to investigate whether the addition of another drug Amifostine can reduce the side effects of current combination treatment radiation and chemotherapy which is standard of care The addition of Amifostine is the investigational part of the study The research study is also looking at the side effects of Amifostine and cancers growth response to this combination treatment
Detailed Description:
Patients presenting with locally advanced squamous cell carcinomas of head and neck SCCHN continue to represent a significant therapeutic challenge The bulk of tumor burden often proves to be overwhelming for conventional radiotherapy Attempts to improve upon these poor outcomes have led investigators to explore several new strategies one such being chemoradiation One of the trials conducted at the University of Maryland with carboplatin and paclitaxel with daily radiation showed 82 CR at the primary site But the most commonly encountered grade 3 toxicities were mucositis 70 leukopenia 30 and 3 grade 4 leukopenia Amifostine An organic thiophosphate is radioprotective and has shown to protect experimental animals from lethal doses of radiation Clinical trials have demonstrated that amifostine can provide protection against the hematological toxicities and mucositis seen with various chemotherapeutic agents Theoretically drug interactions between amifostine and chemotherapeutic agents are not likely to occur due to amifostines rapid clearance from plasma 90 of the drug is cleared within 6 minutes A promising venue would be the investigation of amifostines role in reducing the toxicities associated with chemoradiation which is standard of care of treating squamous cell carcinomas of head and neck
Principal objectives of the study Primary To evaluate whether the addition of the radioprotector amifostine can reduce the incidence and severity of mucositis and hematological toxicities caused by chemoradiation Secondary 1To determine the toxicities of amifostine given in this setting 2 To determine the response rate of this regimen in the population
Principal objectives of the study Primary To evaluate whether the addition of the radioprotector amifostine can reduce the incidence and severity of mucositis and hematological toxicities caused by chemoradiation Secondary 1To determine the toxicities of amifostine given in this setting 2 To determine the response rate of this regimen in the population
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