Status:
WITHDRAWN
A Study to Determine Whether EGFR Status by FISH Can Predict Results in Non Small Cell Lung Cancer (NSCLC) Patients Treated With Cetuximab, Carboplatin and Paclitaxel
Lead Sponsor:
Eli Lilly and Company
Conditions:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine if EGFR status (positive or negative) by FISH can predict response to cetuximab therapy in NSCLC patients treated with carboplatin and paclitaxel
Eligibility Criteria
Inclusion
- Subjects who present with Stage IV, Stage IIIB NSCLC or recurrent disease following radiation therapy or surgical resection
- No prior chemotherapy or anti-EGFR targeted therapy
- Sufficient tumor material for FISH testing
- Measurable disease (RECIST)
- ECOG performance status 0 or 1
Exclusion
- Symptomatic or uncontrolled CNS metastases
- Inadequate hematologic function defined as ANC \< 1,500/mm3, platelet count \< 100,000/mm3, or a hemoglobin level \< 9 g/dl
- Inadequate hepatic function defined as total bilirubin \> 1.25 x ULN, AST level \> 1.5 x ULN, or alkaline phosphatase \> 5.0 x ULN
- Inadequate renal function defined by a serum creatinine level \> 1.5 x ULN
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00768131
Start Date
October 1 2008
End Date
October 1 2008
Last Update
October 28 2015
Active Locations (14)
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1
Local Institution
Little Rock, Arkansas, United States, 72205
2
Local Institution
Long Beach, California, United States, 90813
3
Local Institution
Boynton Beach, Florida, United States, 33435
4
Local Institution
Chicago, Illinois, United States, 60612