Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397384
Status:
COMPLETED
Last Update Posted:
2015-09-30
First Post:
2006-11-08
Brief Title:
Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer Head and Neck Cancer Non-Small Cell Lung Cancer or Colorectal Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Clinical and Biological Evaluation of Combined EGFR Blockade With Erlotinib and Cetuximab in Patients With Advanced Cancer
Status:
COMPLETED
Status Verified Date:
2014-02
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 phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with cetuximab and to see how well they work in treating patients with advanced gastrointestinal cancer head and neck cancer non-small cell lung cancer or colorectal cancer Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Monoclonal antibodies such as cetuximab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Erlotinib hydrochloride and cetuximab may also stop the growth of tumor cells by blocking blood flow to the tumor Giving erlotinib hydrochloride together with cetuximab may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To identify the maximum tolerated dose MTD II To identify the recommended dose RD for phase II of erlotinib erlotinib hydrochloride in combination with cetuximab in patients pts with incurable gastrointestinal head and neck or non-small cell lung cancers that are Kirsten rat sarcoma viral oncogene homolog KRAS wild type
SECONDARY OBJECTIVES
I To identify dose-limiting toxicities DLT II To perform skin and tumor biopsies to analyze molecular inhibition of the epidermal growth factor receptor EGFR signaling pathway defined as a 75 inhibition of phosphorylation of the epidermal growth factor EGF receptor or of its downstream effectors tumor protein p4442 mitogen-activated protein kinase MAPK or protein kinase B Akt or as a 25 decrease of marker of proliferation Ki-67 Ki67 from baseline in either skin or tumor tissue in the majority of patients
III To identify the optimal biological dose OBD IV To describe any antitumor effect observed
OUTLINE This is a phase I dose-escalation study of erlotinib hydrochloride
Patients receive cetuximab intravenously IV over 1-2 hours on days 1 8 and 15 and erlotinib hydrochloride orally PO once daily QD on days 8-21 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 4 weeks
I To identify the maximum tolerated dose MTD II To identify the recommended dose RD for phase II of erlotinib erlotinib hydrochloride in combination with cetuximab in patients pts with incurable gastrointestinal head and neck or non-small cell lung cancers that are Kirsten rat sarcoma viral oncogene homolog KRAS wild type
SECONDARY OBJECTIVES
I To identify dose-limiting toxicities DLT II To perform skin and tumor biopsies to analyze molecular inhibition of the epidermal growth factor receptor EGFR signaling pathway defined as a 75 inhibition of phosphorylation of the epidermal growth factor EGF receptor or of its downstream effectors tumor protein p4442 mitogen-activated protein kinase MAPK or protein kinase B Akt or as a 25 decrease of marker of proliferation Ki-67 Ki67 from baseline in either skin or tumor tissue in the majority of patients
III To identify the optimal biological dose OBD IV To describe any antitumor effect observed
OUTLINE This is a phase I dose-escalation study of erlotinib hydrochloride
Patients receive cetuximab intravenously IV over 1-2 hours on days 1 8 and 15 and erlotinib hydrochloride orally PO once daily QD on days 8-21 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 4 weeks
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 |
|---|---|---|---|
| P30CA068485 | NIH | CTEP | httpsreporternihgovquickSearchP30CA068485 |
| NCI-2009-00107 | REGISTRY | None | None |
| CDR0000511880 | None | None | None |
| GI 0622 | OTHER | None | None |
| 6980 | OTHER | None | None |