Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408499
Status:
COMPLETED
Last Update Posted:
2017-05-08
First Post:
2006-12-06
Brief Title:
Erlotinib and Cetuximab in Treating Patients With Advanced Solid Tumors With Emphasis on Non-Small Cell Lung Cancer
Sponsor:
University of California Davis
Organization:
University of California Davis
Study Overview
Official Title:
Phase III Study of Erlotinib TARCEVA and Cetuximab ERBITUX in Advanced Solid Tumors With Emphasis on Non Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2017-01
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:
RATIONALE Erlotinib 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 Giving erlotinib together with cetuximab may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of erlotinib and cetuximab and to see how well they work in treating patients with advanced solid tumors or progressive or recurrent stage III or stage IV non-small cell lung cancer
PURPOSE This phase III trial is studying the side effects and best dose of erlotinib and cetuximab and to see how well they work in treating patients with advanced solid tumors or progressive or recurrent stage III or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the safety and feasibility of erlotinib hydrochloride and cetuximab in patients with advanced solid tumors Phase I
Determine the efficacy of this regimen in terms of objective tumor response rate in patients with advanced non-small cell lung cancer NSCLC pre-treated with platinum Phase II
Secondary
Determine the maximum tolerated dose of this regimen in these patients Phase I
Determine the efficacy of this regimen in terms of response rate in these patients Phase I
Determine the progression-free and overall survival of patients treated with this regimen Phase II
Determine the frequency and severity of toxicities of this regimen in these patients Phase II
Determine epidermal growth factor receptor EGFR and K-RAS mutation status Phase II
Evaluate EGFR protein expression and protein expression of downstream markers eg pMAPK pAKT p27 and Ki-67 Phase II
Evaluate the levels of marker proteins eg pMAPK pAKT p27 and Ki-67 in buccal cells Phase II
Determine gene copy number by EGFR fluorescent in situ hybridization FISH Phase II
Identify EGFR polymorphisms by analysis of genomic DNA from peripheral blood mononuclear cells Phase II
Determine if the continued presence or absence of mutant K-RAS tumor DNA correlates with response andor outcome Phase II
OUTLINE This is a phase I dose-escalation study followed by an open-label phase II study
Phase I Patients receive oral erlotinib hydrochloride once daily on days 1-28 and cetuximab IV over 1-2 hours on days 1 8 15 and 22 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride and cetuximab 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 At least 6 patients are treated at the MTD
Phase II Patients receive erlotinib hydrochloride and cetuximab at the MTD determined in phase I
Blood and buccal samples are acquired from patients at baseline and prior to courses 2 and 3 Samples are examined by fluorescent in situ hybridization FISH immunohistochemistry polymorphism analysis and protein expression assays to assess molecular markers epidermal growth factor receptor K-RAS pMAPK pAKT p27 and Ki-67 for biologic effects and predictive response
After completion of phase I treatment patients are followed for 30 days or until all toxicities resolve After completion of phase II treatment patients are followed periodically
PROJECTED ACCRUAL A total of 62 patients will be accrued for this study
Primary
Determine the safety and feasibility of erlotinib hydrochloride and cetuximab in patients with advanced solid tumors Phase I
Determine the efficacy of this regimen in terms of objective tumor response rate in patients with advanced non-small cell lung cancer NSCLC pre-treated with platinum Phase II
Secondary
Determine the maximum tolerated dose of this regimen in these patients Phase I
Determine the efficacy of this regimen in terms of response rate in these patients Phase I
Determine the progression-free and overall survival of patients treated with this regimen Phase II
Determine the frequency and severity of toxicities of this regimen in these patients Phase II
Determine epidermal growth factor receptor EGFR and K-RAS mutation status Phase II
Evaluate EGFR protein expression and protein expression of downstream markers eg pMAPK pAKT p27 and Ki-67 Phase II
Evaluate the levels of marker proteins eg pMAPK pAKT p27 and Ki-67 in buccal cells Phase II
Determine gene copy number by EGFR fluorescent in situ hybridization FISH Phase II
Identify EGFR polymorphisms by analysis of genomic DNA from peripheral blood mononuclear cells Phase II
Determine if the continued presence or absence of mutant K-RAS tumor DNA correlates with response andor outcome Phase II
OUTLINE This is a phase I dose-escalation study followed by an open-label phase II study
Phase I Patients receive oral erlotinib hydrochloride once daily on days 1-28 and cetuximab IV over 1-2 hours on days 1 8 15 and 22 Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride and cetuximab 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 At least 6 patients are treated at the MTD
Phase II Patients receive erlotinib hydrochloride and cetuximab at the MTD determined in phase I
Blood and buccal samples are acquired from patients at baseline and prior to courses 2 and 3 Samples are examined by fluorescent in situ hybridization FISH immunohistochemistry polymorphism analysis and protein expression assays to assess molecular markers epidermal growth factor receptor K-RAS pMAPK pAKT p27 and Ki-67 for biologic effects and predictive response
After completion of phase I treatment patients are followed for 30 days or until all toxicities resolve After completion of phase II treatment patients are followed periodically
PROJECTED ACCRUAL A total of 62 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 |
|---|---|---|---|
| BMS-CA225-261 | OTHER | Bristol Myers Squibb | httpsreporternihgovquickSearchP30CA093373 |
| P30CA093373 | NIH | None | None |
| UCDCC-177 | OTHER | None | None |
| BMS-4608 | OTHER | None | None |