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
Withdrawn before enrolling · Phase 2
Conditions studied: Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
In brief
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
Key facts
- Study ID
- NCT00768131
- Run by
- Eli Lilly and Company
- People needed
- 0
- Starts
- 2008-10-01
- Expected to finish
- 2008-10-01
- Last updated by the study team
- 2015-10-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Local Institution — Little Rock, Arkansas, United States
- Local Institution — Long Beach, California, United States
- Local Institution — Boynton Beach, Florida, United States
- Local Institution — Chicago, Illinois, United States
- Local Institution — Skokie, Illinois, United States
- Local Institution — Wichita, Kansas, United States
- Local Institution — Louisville, Kentucky, United States
- Local Institution — Mount Sterling, Kentucky, United States
- Local Institution — Annapolis, Maryland, United States
- Local Institution — Kalamazoo, Michigan, United States
- Local Institution — Staten Island, New York, United States
- Local Institution — Winston-Salem, North Carolina, United States
- Local Institution — Portland, Oregon, United States
- Local Institution — Austin, Texas, United States
Full record on ClinicalTrials.gov
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