Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-25 @ 5:22 PM
Study NCT ID:
NCT00216203
Status:
COMPLETED
Last Update Posted:
2016-09-29
First Post:
2005-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pemetrexed Plus Cetuximab in Patients With Recurrent Non Small Cell Lung Cancer
Sponsor:
Nasser Hanna, M.D.
Organization:
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 400mg/m2
Week 2 (Cycle 1, Day 1):
* Cetuximab 250mg/m2 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 \> 1,500/mm3
* Platelets \> 100,000/mm3
Hepatic:
* Bilirubin less than or equal to the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) \< 1.5 X ULN. AST may be \< 5 X ULN for patients with liver metastases
* Alkaline phosphatase \< 5 X ULN
Renal:
* Calculated creatinine clearance \> 45 mL/min (by Cockcroft-Gault)
Cardiovascular:
* No significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, and congestive heart failure)
Pulmonary:
* Not specified
Week 1 (day 1):
* Cetuximab 400mg/m2
Week 2 (Cycle 1, Day 1):
* Cetuximab 250mg/m2 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 \> 1,500/mm3
* Platelets \> 100,000/mm3
Hepatic:
* Bilirubin less than or equal to the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) \< 1.5 X ULN. AST may be \< 5 X ULN for patients with liver metastases
* Alkaline phosphatase \< 5 X ULN
Renal:
* Calculated creatinine clearance \> 45 mL/min (by Cockcroft-Gault)
Cardiovascular:
* No significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, and congestive heart failure)
Pulmonary:
* Not specified
Study Oversight
Has Oversight DMC:
True
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?: