Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00097227
Status:
COMPLETED
Last Update Posted:
2010-04-09
First Post:
2004-11-18
Brief Title:
Trial of CarboplatinPaclitaxelCetuximab in Stage IIIBIV Non-Small Cell Lung Cancer NSCLC
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Randomized Phase II Trial of Two Dose Schedules of CarboplatinPaclitaxelCetuximab in 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:
The purpose of the study is to determine if the combination of cetuximab carboplatin and paclitaxel will shrink a specific type of lung cancer known as non-small cell lung cancer NSCLC The safety of this combination will also be evaluated
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 two chemotherapy agents carboplatin and paclitaxel 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 previous studies incorporating cetuximab into each of two regimens of paclitaxel plus carboplatin The results of prior studies using paclitaxel and carboplatin demonstrate that these drugs in combination using a variety of schedules are both safe and effective as therapy for advanced or metastatic NSCLC The addition of biologic therapy with the anti-EGFR agent cetuximab to the combination will presumably maximize the therapeutic index while keeping toxicity to a minimum in patients with Stage IIIBIV NSCLC
Research Hypothesis
Subjects with previously-untreated stage IIIBIV NSCLC who receive a combination of paclitaxel carboplatin and cetuximab will have a progression-free survival rate greater than that previously reported for subjects receiving the combination of paclitaxel and carboplatin
Rationale
The present study is built upon the data from previous studies incorporating cetuximab into each of two regimens of paclitaxel plus carboplatin The results of prior studies using paclitaxel and carboplatin demonstrate that these drugs in combination using a variety of schedules are both safe and effective as therapy for advanced or metastatic NSCLC The addition of biologic therapy with the anti-EGFR agent cetuximab to the combination will presumably maximize the therapeutic index while keeping toxicity to a minimum in patients with Stage IIIBIV NSCLC
Research Hypothesis
Subjects with previously-untreated stage IIIBIV NSCLC who receive a combination of paclitaxel carboplatin and cetuximab will have a progression-free survival rate greater than that previously reported for subjects receiving the combination of paclitaxel and carboplatin
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