Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352105
Status:
COMPLETED
Last Update Posted:
2012-11-04
First Post:
2006-07-13
Brief Title:
Cisplatin Fluorouracil Iressa and Radiation Therapy Patients With Locally Advanced Head and Neck Cancer
Sponsor:
David Adelstein
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase III Trial of Concurrent Chemotherapy and ZD1839 IRESSA With Hyperfractionated Radiation Therapy Followed by Maintenance ZD1839 IRESSA for Patients With Locally Advanced Squamous Cell Head and Neck Cancer
Status:
COMPLETED
Status Verified Date:
2012-11
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:
RATIONALE Drugs used in chemotherapy such as cisplatin and fluorouracil work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Radiation therapy uses high-energy x-rays to kill tumor cells Giving cisplatin fluorouracil and gefitinib together with radiation therapy may kill more tumor cells
PURPOSE This phase III trial is studying the side effects of giving cisplatin fluorouracil and gefitinib together with hyperfractionated radiation therapy and to see how well they work in treating patients with locally advanced head and neck cancer
PURPOSE This phase III trial is studying the side effects of giving cisplatin fluorouracil and gefitinib together with hyperfractionated radiation therapy and to see how well they work in treating patients with locally advanced head and neck cancer
Detailed Description:
OBJECTIVES
Primary
Explore the activity of cisplatin fluorouracil gefitinib and hyperfractionated radiotherapy in terms of 1-year survival and 1-year distant metastatic disease control in patients with locally advanced squamous cell carcinoma of the head and neck
Secondary
Explore the activity of this regimen in terms of disease-specific survival and local control in these patients
Assess the toxicity of this regimen in these patients
Assess the complete response rate in patients treated with this regimen
Assess the toxicity and tolerability of long-term maintenance with gefitinib in patients rendered disease free after this treatment regimen
OUTLINE Patients undergo hyperfractionated radiotherapy twice daily 5 days a week beginning on day 1 and continuing for 6 weeks Patients also receive fluorouracil IV continuously over 96 hours and cisplatin IV continuously over 96 hours on days 1-4 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3-6 months
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Primary
Explore the activity of cisplatin fluorouracil gefitinib and hyperfractionated radiotherapy in terms of 1-year survival and 1-year distant metastatic disease control in patients with locally advanced squamous cell carcinoma of the head and neck
Secondary
Explore the activity of this regimen in terms of disease-specific survival and local control in these patients
Assess the toxicity of this regimen in these patients
Assess the complete response rate in patients treated with this regimen
Assess the toxicity and tolerability of long-term maintenance with gefitinib in patients rendered disease free after this treatment regimen
OUTLINE Patients undergo hyperfractionated radiotherapy twice daily 5 days a week beginning on day 1 and continuing for 6 weeks Patients also receive fluorouracil IV continuously over 96 hours and cisplatin IV continuously over 96 hours on days 1-4 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3-6 months
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
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 |
|---|---|---|---|
| ZENECA-18390235 | Other Identifier | Cleveland Clinic IRB | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CCF-5842 | OTHER | None | None |