Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097214
Status:
COMPLETED
Last Update Posted:
2010-04-09
First Post:
2004-11-18
Brief Title:
Carboplatin Plus Cetuximab for Treatment of Stage IIIBIV Non-Small Cell Lung Cancer NSCLC
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Phase II Trial of Carboplatin Plus Cetuximab for the Treatment of Stage IIIbIV Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2010-04
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 is a phase II study in previously untreated subjects with histologically or cytologically proven stage IIIBIV NSCLC designed to determine the efficacy of first line treatment with carboplatin and cetuximab
Detailed Description:
Lung cancer is the second most common cancer diagnosed for both genders in the United States Approximately 173770 new cases are estimated for 2004 It is the leading cause of cancer deaths in both men and women with approximately 160440 deaths estimated for 2004 Prognosis for many is poor if not diagnosed at an early stage and therapy for advanced disease is limited The study will test carboplatin in combination with a newly approved drug called cetuximab which is continuing to be tested in colorectal cancer and other cancers Cetuximab is a monoclonal antibody which is believed to work by attaching to an epidermal growth factor receptor EGFR on tumor cells and thereby blocking tumor cells from reproducing It is an antibody to the EGFR Fifty percent of lung cancers overexpress EGFR
Rationale
The present study is built upon the data from the described studies incorporating cetuximab into a regimen of single-agent carboplatin Previous data suggest that single agent carboplatin is active in NSCLC The addition of biologic therapy with the anti-EGFR agent cetuximab to carboplatin will presumably maximize the therapeutic index while keeping toxicity to a minimum in patients with Stage IIIBIV NSCLC
Research Hypothesis
The population being studied in this trial is subjects with previously untreated Stage IIIB or IV NSCLC The research hypothesis is that these subjects will achieve a response based on RECIST criteria to therapy with the combination of carboplatin and cetuximab
Rationale
The present study is built upon the data from the described studies incorporating cetuximab into a regimen of single-agent carboplatin Previous data suggest that single agent carboplatin is active in NSCLC The addition of biologic therapy with the anti-EGFR agent cetuximab to carboplatin will presumably maximize the therapeutic index while keeping toxicity to a minimum in patients with Stage IIIBIV NSCLC
Research Hypothesis
The population being studied in this trial is subjects with previously untreated Stage IIIB or IV NSCLC The research hypothesis is that these subjects will achieve a response based on RECIST criteria to therapy with the combination of carboplatin and cetuximab
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