NCT00768131

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

14 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 7, 2008

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

Same day

First QC Date

October 6, 2008

Last Update Submit

October 26, 2015

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival (PFS) will be compared for FISH positive subjects (subset) receiving paclitaxel / carboplatin +/- cetuximab

    Every 6 weeks

Secondary Outcomes (5)

  • Tumor response

    Every 6 weeks

  • Disease control

    Every 6 weeks

  • Overall survival (OS)

    Every 4 months after subject off-treatment until 1 year after LPLT

  • Duration of Response

    Every 6 weeks

  • Safety & exploratory biomarker analysis

    Every 3 weeks

Study Arms (4)

A1 FISH (+)

EXPERIMENTAL
Drug: CetuximabDrug: PaclitaxelDrug: Carboplatin

B1 FISH (+)

ACTIVE COMPARATOR
Drug: PaclitaxelDrug: Carboplatin

A2 FISH (-)

EXPERIMENTAL
Drug: CetuximabDrug: PaclitaxelDrug: Carboplatin

B2 FISH (-)

ACTIVE COMPARATOR
Drug: PaclitaxelDrug: Carboplatin

Interventions

CetuximabDRUG

Vial, Intravenous, 400 mg/m² week 1 then 250 mg/m², Weekly, Until PD/Toxicity/Pt-PI Decision

Also known as: Erbitux, BMS-564717
A1 FISH (+)A2 FISH (-)
PaclitaxelDRUG

Vial, Intravenous, 225 mg/m2, Every 3 weeks, 6 cycles maximum

A1 FISH (+)A2 FISH (-)B1 FISH (+)B2 FISH (-)
CarboplatinDRUG

Vial, Intravenous, AUC = 6.0, Every 3 weeks, 6 cycles maximum

A1 FISH (+)A2 FISH (-)B1 FISH (+)B2 FISH (-)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Local Institution

Little Rock, Arkansas, 72205, United States

Location

Local Institution

Long Beach, California, 90813, United States

Location

Local Institution

Boynton Beach, Florida, 33435, United States

Location

Local Institution

Chicago, Illinois, 60612, United States

Location

Local Institution

Skokie, Illinois, 60076, United States

Location

Local Institution

Wichita, Kansas, 67214, United States

Location

Local Institution

Louisville, Kentucky, 40207, United States

Location

Local Institution

Mount Sterling, Kentucky, 40353, United States

Location

Local Institution

Annapolis, Maryland, 21401, United States

Location

Local Institution

Kalamazoo, Michigan, 49048, United States

Location

Local Institution

Staten Island, New York, 10310, United States

Location

Local Institution

Winston-Salem, North Carolina, 27103, United States

Location

Local Institution

Portland, Oregon, 97213, United States

Location

Local Institution

Austin, Texas, 78705, United States

Location

Related Links

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

CetuximabPaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2008

First Posted

October 7, 2008

Study Start

October 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

October 28, 2015

Record last verified: 2015-10

Locations

US(14)