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
NCT ID: NCT00768131
Last Updated: 2015-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2008-10-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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A1 FISH (+)
Cetuximab
Vial, Intravenous, 400 mg/m² week 1 then 250 mg/m², Weekly, Until PD/Toxicity/Pt-PI Decision
Paclitaxel
Vial, Intravenous, 225 mg/m2, Every 3 weeks, 6 cycles maximum
Carboplatin
Vial, Intravenous, AUC = 6.0, Every 3 weeks, 6 cycles maximum
B1 FISH (+)
Paclitaxel
Vial, Intravenous, 225 mg/m2, Every 3 weeks, 6 cycles maximum
Carboplatin
Vial, Intravenous, AUC = 6.0, Every 3 weeks, 6 cycles maximum
A2 FISH (-)
Cetuximab
Vial, Intravenous, 400 mg/m² week 1 then 250 mg/m², Weekly, Until PD/Toxicity/Pt-PI Decision
Paclitaxel
Vial, Intravenous, 225 mg/m2, Every 3 weeks, 6 cycles maximum
Carboplatin
Vial, Intravenous, AUC = 6.0, Every 3 weeks, 6 cycles maximum
B2 FISH (-)
Paclitaxel
Vial, Intravenous, 225 mg/m2, Every 3 weeks, 6 cycles maximum
Carboplatin
Vial, Intravenous, AUC = 6.0, Every 3 weeks, 6 cycles maximum
Interventions
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Cetuximab
Vial, Intravenous, 400 mg/m² week 1 then 250 mg/m², Weekly, Until PD/Toxicity/Pt-PI Decision
Paclitaxel
Vial, Intravenous, 225 mg/m2, Every 3 weeks, 6 cycles maximum
Carboplatin
Vial, Intravenous, AUC = 6.0, Every 3 weeks, 6 cycles maximum
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No prior chemotherapy or anti-EGFR targeted therapy
* Sufficient tumor material for FISH testing
* Measurable disease (RECIST)
* ECOG performance status 0 or 1
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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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
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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CA225-322
Identifier Type: -
Identifier Source: org_study_id
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