Clinical trial NCT00768131: 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
Official title: A Randomized Phase II Trial to Assess the Predictive Value of Increased EGFR Copy Number by FISH in Patients With Advanced / Metastatic NSCLC Treated With Cetuximab and Carboplatin / Paclitaxel
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-10-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 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

Primary outcomes:
measure: Progression Free Survival (PFS) will be compared for FISH positive subjects (subset) receiving paclitaxel / carboplatin +/- cetuximab
timeFrame: Every 6 weeks
Secondary outcomes:
measure: Tumor response
timeFrame: Every 6 weeks
measure: Disease control
timeFrame: Every 6 weeks
measure: Overall survival (OS)
timeFrame: Every 4 months after subject off-treatment until 1 year after LPLT
measure: Duration of Response
timeFrame: Every 6 weeks
measure: Safety & exploratory biomarker analysis
timeFrame: Every 3 weeks
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Local Institution
state: Arkansas
city: Long Beach
country: United States
facility: Local Institution
state: California
city: Boynton Beach
country: United States
facility: Local Institution
state: Florida
city: Chicago
country: United States
facility: Local Institution
state: Illinois
city: Skokie
country: United States
facility: Local Institution
state: Illinois
city: Wichita
country: United States
facility: Local Institution
state: Kansas
city: Louisville
country: United States
facility: Local Institution
state: Kentucky
city: Mt. Sterling
country: United States
facility: Local Institution
state: Kentucky
city: Annapolis
country: United States
facility: Local Institution
state: Maryland
city: Kalamazoo
country: United States
facility: Local Institution
state: Michigan
city: Staten Island
country: United States
facility: Local Institution
state: New York
city: Winston-Salem
country: United States
facility: Local Institution
state: North Carolina
city: Portland
country: United States
facility: Local Institution
state: Oregon
city: Austin
country: United States
facility: Local Institution
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: