NCT00063388

Brief Summary

Determine tumor response rate and time to disease progression, survival and safety in total populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2003

Geographic Reach
1 country

8 active sites

Status
completed

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

May 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2003

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

April 12, 2010

Status Verified

April 1, 2010

Enrollment Period

2.1 years

First QC Date

June 25, 2003

Last Update Submit

April 8, 2010

Conditions

Non-Small-Cell Lung Cancer

Keywords

NonSmallCellLungCancer

Outcome Measures

Primary Outcomes (1)

  • The primary objective of this study was to determine the tumor response rate for single-agent cetuximab in EGFR+ subjects.

    Every 8 weeks

Secondary Outcomes (4)

  • Determine the tumor response rate in the total population and in EGFR- subjects

    Every 8 weeks

  • Time to disease progression in the EGFR+ and total populations.

    Every 8 weeks

  • Survival in the EGFR+ and total populations.

    Every 8 weeks

  • Safety in the EGFR+ and total populations.

    Every 8 weeks

Study Arms (1)

1

EXPERIMENTAL

Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes).

Biological: Cetuximab

Interventions

CetuximabBIOLOGICAL

Cetuximab 400 mg/m2 intravenously (IV) (over 120 minutes) on Day 1 of Cycle 1. followed by weekly doses of 250 mg/m2 (over 60 minutes).

Also known as: Erbitux
1

Eligibility Criteria

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

You may qualify if:

  • Subjects with recurrent or progressive NSCLC with either present or prior histologic confirmation or pathologic confirmation of NSCLC
  • Subjects receiving 1 or more prior chemotherapy regimens for the treatment of recurrent/metastatic disease, including at least 1 platinum-based combination
  • Unidimensionally measurable NSCLC
  • Subjects with tumor tissue available for EGFR assessment
  • ECOG performance status of 0 or 1
  • Subjects with asymptomatic brain metastasis were eligible; however, they must have completed radiotherapy/radiosurgery at least 3 weeks prior to enrollment and have been off steroids

You may not qualify if:

  • Women of childbearing potential who were unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the study. Male subjects must also have agreed to use effective contraception
  • Women of childbearing potential using a prohibited contraceptive method
  • Women who were pregnant or breastfeeding
  • Women with a positive pregnancy test on enrollment or prior to study drug administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

ImClone Investigational Site

Aventura, Florida, 33180, United States

Location

ImClone Investigational Site

Miami Beach, Florida, 33140, United States

Location

ImClone Investigational Site

Chicago, Illinois, 60612, United States

Location

ImClone Investigational Site

Indianapolis, Indiana, 46202, United States

Location

ImClone Investigational Site

South Bend, Indiana, 46601, United States

Location

ImClone Investigational Site

Boston, Massachusetts, 02114, United States

Location

ImClone Investigational Site

Boston, Massachusetts, 02115, United States

Location

ImClone Investigational Site

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungCerebral PalsyNeoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesBrain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • E-mail: ClinicalTrials@ ImClone.com

    Eli Lilly and Company

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 25, 2003

First Posted

June 27, 2003

Study Start

May 1, 2003

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

April 12, 2010

Record last verified: 2010-04

Locations

US(8)