Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00079053
Status:
COMPLETED
Last Update Posted:
2023-08-04
First Post:
2004-03-08
Brief Title:
Adjuvant Erlotinib After Completing Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
Official Title:
A Phase I Study of Adjuvant OSI-774 Tarceva in Patients Following Combined Chemo-Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Status:
COMPLETED
Status Verified Date:
2020-04
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 Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Giving erlotinib after chemoradiotherapy may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of adjuvant erlotinib when given after completing chemoradiotherapy in treating patients with locally advanced squamous cell carcinoma cancer of the head and neck
PURPOSE This phase I trial is studying the side effects and best dose of adjuvant erlotinib when given after completing chemoradiotherapy in treating patients with locally advanced squamous cell carcinoma cancer of the head and neck
Detailed Description:
OBJECTIVES
Primary
Determine the recommended dose of adjuvant erlotinib after the completion of chemoradiotherapy in patients with stage III IVA or IVB squamous cell carcinoma of the head and neck
Determine the toxicity of this drug in these patients
Determine the effects of this drug on plasma and urinary angiogenic factors specifically vascular endothelial growth factor receptor VEGFR VEGFR1 VEGFR2 and basic fibroblast growth factor levels in these patients
Compare the disease-free survival of patients treated with this drug after chemoradiotherapy vs historical control patients treated with chemoradiotherapy alone
Correlate levels of angiogenic factors with initial blood vessel concentration in the tumor and the presence or absence of EGFRvIII mutation in patients treated with this drug
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive oral erlotinib once daily on days 1-28 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional 8 patients are treated at that dose level
Patients are followed at 4 weeks every 12 weeks for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 6-20 patients will be accrued for this study
Primary
Determine the recommended dose of adjuvant erlotinib after the completion of chemoradiotherapy in patients with stage III IVA or IVB squamous cell carcinoma of the head and neck
Determine the toxicity of this drug in these patients
Determine the effects of this drug on plasma and urinary angiogenic factors specifically vascular endothelial growth factor receptor VEGFR VEGFR1 VEGFR2 and basic fibroblast growth factor levels in these patients
Compare the disease-free survival of patients treated with this drug after chemoradiotherapy vs historical control patients treated with chemoradiotherapy alone
Correlate levels of angiogenic factors with initial blood vessel concentration in the tumor and the presence or absence of EGFRvIII mutation in patients treated with this drug
OUTLINE This is an open-label dose-escalation multicenter study
Patients receive oral erlotinib once daily on days 1-28 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 6 patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined an additional 8 patients are treated at that dose level
Patients are followed at 4 weeks every 12 weeks for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 6-20 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000353485 | OTHER | PDQ | None |
| CAN-NCIC-HN5 | OTHER | None | None |
| ROCHE-CAN-NCIC-HN5 | OTHER | None | None |