NCT00034346

Brief Summary

Rationale: Overexpression of epidermal growth factor receptor (EGFR) has been observed in kidney, prostate, colon, lung, breast, and other cancers, and is often associated with a poor prognosis. TGFa and EGF, the ligands for EGFR, are also overexpressed in some of these tumor types, suggesting a self-propagating stimulus that may be responsible for rapid tumor growth. Blocking this stimulus by blocking activation of EGFR with ABX-EGF, a fully human monoclonal antibody against EGFR, may prevent tumor growth and perhaps shrink tumors. Purpose: This is a Phase 2 clinical trial to evaluate the safety and efficacy of ABX-EGF in combination with paclitaxel and carboplatin in the treatment of advanced NSCLC.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
194

participants targeted

Target at P75+ for phase_2 nonsmall-cell-lung-cancer

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

January 1, 2002

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 25, 2002

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2002

Completed
Last Updated

December 24, 2007

Status Verified

December 1, 2007

First QC Date

April 25, 2002

Last Update Submit

December 20, 2007

Conditions

Non-Small Cell Lung CancerNeoplasm MetastasisLung Cancer

Keywords

AdvancedNon-Small-CellLungCancerNSCLCCarcinomaAdvanced Non-Small-Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

  • Time to Disease Progression

Secondary Outcomes (9)

  • Best Overall Response Rate

  • Response Rate at Week 5

  • Survival Time

  • Progression Free Survival

  • Rate of Progressive Disease at Week 11

  • +4 more secondary outcomes

Interventions

ABX-EGFDRUG
paclitaxelDRUG
carboplatinDRUG

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell LungNeoplasm MetastasisLung NeoplasmsNeoplasmsCarcinoma

Interventions

PanitumumabPaclitaxelCarboplatin

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteLung DiseasesRespiratory Tract DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

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

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

April 25, 2002

First Posted

April 26, 2002

Study Start

January 1, 2002

Last Updated

December 24, 2007

Record last verified: 2007-12