Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00216203
Status:
COMPLETED
Last Update Posted:
2016-09-29
First Post:
2005-09-12
Brief Title:
Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer
Sponsor:
Nasser Hanna MD
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Phase I-IIa Dose-Ranging Study of Pemetrexed Alimta Plus Cetuximab Erbitux in Patients With Recurrent Non-Small Cell Lung Cancer NSCLC Hoosier Oncology Group LUN04-79
Status:
COMPLETED
Status Verified Date:
2016-08
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:
Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping toxicity profiles While 2-drug combination therapy has proven superior to single agent therapy in the first-line setting of NSCLC no such phase III trials have been reported in the second-line setting Therefore the purpose of this study is to determine the feasibility of combining these drugs assessing the toxicity profile determining the MTD and evaluating the activity of the combination in an expanded phase II setting If the combination appears to have promising activity further evaluation of this regimen may be warranted comparing it to single agent pemetrexed or cetuximab alone
Detailed Description:
OUTLINE This is a multi-center study
Week 1 day 1
Cetuximab 400mgm2
Week 2 Cycle 1 Day 1
Cetuximab 250mgm2 plus premetrexed at the assigned dose level
Patients will be treated with cetuximab on day 1 8 15 of each 21 day cycle
Patients will be treated with pemetrexed on day 1 of each 21 day cycle for a maximum of 6 cycles
Acceptable toxicity and SD PR or CR treat up to 6 cycles then continue cetuximab weekly until PD or excess toxicity
Performance status ECOG 0-2
Life expectancy At least 12 weeks
Hematopoietic
ANC 1500mm3
Platelets 100000mm3
Hepatic
Bilirubin less than or equal to the upper limit of normal ULN
Aspartate aminotransferase AST 15 X ULN AST may be 5 X ULN for patients with liver metastases
Alkaline phosphatase 5 X ULN
Renal
Calculated creatinine clearance 45 mLmin by Cockcroft-Gault
Cardiovascular
No significant history of uncontrolled cardiac disease ie uncontrolled hypertension unstable angina and congestive heart failure
Pulmonary
Not specified
Week 1 day 1
Cetuximab 400mgm2
Week 2 Cycle 1 Day 1
Cetuximab 250mgm2 plus premetrexed at the assigned dose level
Patients will be treated with cetuximab on day 1 8 15 of each 21 day cycle
Patients will be treated with pemetrexed on day 1 of each 21 day cycle for a maximum of 6 cycles
Acceptable toxicity and SD PR or CR treat up to 6 cycles then continue cetuximab weekly until PD or excess toxicity
Performance status ECOG 0-2
Life expectancy At least 12 weeks
Hematopoietic
ANC 1500mm3
Platelets 100000mm3
Hepatic
Bilirubin less than or equal to the upper limit of normal ULN
Aspartate aminotransferase AST 15 X ULN AST may be 5 X ULN for patients with liver metastases
Alkaline phosphatase 5 X ULN
Renal
Calculated creatinine clearance 45 mLmin by Cockcroft-Gault
Cardiovascular
No significant history of uncontrolled cardiac disease ie uncontrolled hypertension unstable angina and congestive heart failure
Pulmonary
Not specified
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