Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00410826
Status:
COMPLETED
Last Update Posted:
2013-05-10
First Post:
2006-12-11
Brief Title:
Cisplatin and Radiation Therapy With or Without Erlotinib Hydrochloride in Treating Patients With Stage III or Stage IV Head and Neck Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Multicenter Randomized Phase II Study of Erlotinib Cisplatin and Radiotherapy Versus Cisplatin and Radiotherapy in Patients With Stage III and IV Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2013-05
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 randomized phase II trial is studying cisplatin and radiation therapy together with or without erlotinib hydrochloride to compare how well they work in treating patients with stage III or stage IV head and neck cancer Drugs used in chemotherapy such as cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth It may also make tumor cells more sensitive to radiation therapy Giving cisplatin and radiation therapy together with erlotinib hydrochloride may kill more tumor cells It is not yet known whether cisplatin and radiation therapy are more effective with or without erlotinib hydrochloride in treating head and neck cancer
Detailed Description:
PRIMARY OBJECTIVES
I Compare the complete response rate in patients with locally advanced head and neck cancer treated with cisplatin radiotherapy and erlotinib erlotinib hydrochloride versus cisplatin and radiotherapy alone
SECONDARY OBJECTIVES
I Evaluate whether the addition of erlotinib increases the acute and long term toxicities of cisplatin and radiotherapy in patients with locally advanced head and neck cancer
II Compare the disease-free and overall survivals of patients with locally advanced head and neck cancer treated with cisplatin and radiotherapy with and without erlotinib
III Evaluate whether the symptomatic improvement observed in the first week of erlotinib alone predicts for complete response and long term disease control
IV Correlate epidermal growth factor receptor EGFR p16 and excision repair cross-complementing 1 ERCC-1 expression with response outcome to therapy with cisplatin and radiation with and without erlotinib
V Identify other molecular correlates that may be relevant in the pathogenesis of squamous cell carcinoma of head and neck SCCHN or response to therapy
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive cisplatin intravenously IV on days 1 22 and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily 5 days per week on days 1-47 Patients also receive erlotinib hydrochloride orally PO once daily QD on days -7 to 47
ARM II Patients receive cisplatin and undergo radiotherapy as in Arm I
Within 10-14 weeks after completion of study treatment patients with N2 or N3 disease at the time of screening undergo a neck dissection
After completion of study treatment patients are followed up periodically for 5 years
I Compare the complete response rate in patients with locally advanced head and neck cancer treated with cisplatin radiotherapy and erlotinib erlotinib hydrochloride versus cisplatin and radiotherapy alone
SECONDARY OBJECTIVES
I Evaluate whether the addition of erlotinib increases the acute and long term toxicities of cisplatin and radiotherapy in patients with locally advanced head and neck cancer
II Compare the disease-free and overall survivals of patients with locally advanced head and neck cancer treated with cisplatin and radiotherapy with and without erlotinib
III Evaluate whether the symptomatic improvement observed in the first week of erlotinib alone predicts for complete response and long term disease control
IV Correlate epidermal growth factor receptor EGFR p16 and excision repair cross-complementing 1 ERCC-1 expression with response outcome to therapy with cisplatin and radiation with and without erlotinib
V Identify other molecular correlates that may be relevant in the pathogenesis of squamous cell carcinoma of head and neck SCCHN or response to therapy
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive cisplatin intravenously IV on days 1 22 and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily 5 days per week on days 1-47 Patients also receive erlotinib hydrochloride orally PO once daily QD on days -7 to 47
ARM II Patients receive cisplatin and undergo radiotherapy as in Arm I
Within 10-14 weeks after completion of study treatment patients with N2 or N3 disease at the time of screening undergo a neck dissection
After completion of study treatment patients are followed up periodically for 5 years
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 |
|---|---|---|---|
| NCI-2009-01546 | REGISTRY | CTRP Clinical Trial Reporting Program | None |