Ignite Creation Date:
2024-05-05 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00098631
Status:
COMPLETED
Last Update Posted:
2014-01-07
First Post:
2004-12-07
Brief Title:
Lapatinib in Treating Patients With Recurrent andor Metastatic Head and Neck Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of GW572016 In Squamous Cell Carcinoma Of The Head And Neck SCCHN
Status:
COMPLETED
Status Verified Date:
2014-01
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:
Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth This phase II trial is studying how well lapatinib works in treating patients with recurrent andor metastatic head and neck cancer
Detailed Description:
PRIMARY OBJECTIVES
I Determine the overall response rate in patients with recurrent andor metastatic squamous cell carcinoma of the head and neck treated with lapatinib
II Determine the progression-free survival time to progression and overall survival of patients treated with this drug
III Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study Patients are assigned to 1 of 2 cohorts according to prior epidermal growth factor receptor-targeted therapy yes vs no
Patients receive oral lapatinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 40-88 patients 21-50 epidermal growth factor receptor EGFR inhibitor-naive patients cohort A and 19-38 EGFR inhibitor-pre-treated patients cohort B will be accrued for this study within 4-126 months
I Determine the overall response rate in patients with recurrent andor metastatic squamous cell carcinoma of the head and neck treated with lapatinib
II Determine the progression-free survival time to progression and overall survival of patients treated with this drug
III Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study Patients are assigned to 1 of 2 cohorts according to prior epidermal growth factor receptor-targeted therapy yes vs no
Patients receive oral lapatinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 40-88 patients 21-50 epidermal growth factor receptor EGFR inhibitor-naive patients cohort A and 19-38 EGFR inhibitor-pre-treated patients cohort B will be accrued for this study within 4-126 months
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-2012-02636 | REGISTRY | None | None |
| CDR0000398163 | None | None | None |
| UCCRC-13394 | None | None | None |
| NCI-6718 | None | None | None |
| 13394A | OTHER | None | None |
| 6718 | OTHER | None | None |
| N01CM62201 | NIH | None | None |
| N01CM62209 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62209 |