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WithdrawnPhase 2NCT00768131

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

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

Checked against the public recordLast updated Oct 28, 2015 · Source: ClinicalTrials.gov

StatusWithdrawn
PhasePhase 2
U.S. locations14
SponsorEli Lilly and Company
01
Study overview

What this study is about

Purpose
Not specified
Study type
Interventional
Phase
Phase 2
Sponsor
Eli Lilly and Company
Interventions being studied
Drug: Cetuximab; Drug: Paclitaxel; Drug: Carboplatin
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type
Non-small cell lung cancer (NSCLC)→
Biomarkers
EGFR→
Treatment approach
Chemotherapy→
03
Public criteria

Who may be able to participate

Inclusion Criteria: * 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 Criteria: * 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Local InstitutionLittle Rock, Arkansas
  • Local InstitutionLong Beach, California
  • Local InstitutionBoynton Beach, Florida
  • Local InstitutionChicago, Illinois
  • Local InstitutionSkokie, Illinois
  • Local InstitutionWichita, Kansas
  • Local InstitutionLouisville, Kentucky
  • Local InstitutionMount Sterling, Kentucky
  • Local InstitutionAnnapolis, Maryland
  • Local InstitutionKalamazoo, Michigan
  • Local InstitutionStaten Island, New York
  • Local InstitutionWinston-Salem, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 28, 2015. Always confirm current availability with the study team.

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