NCT00062101

Brief Summary

This phase II trial is studying how well giving erlotinib together with celecoxib works in treating patients with recurrent stage IIIB or stage IV non-small cell lung cancer. Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of a tumor by stopping blood flow to the tumor. Combining erlotinib with celecoxib may kill more tumor cells. .

Trial Health

80
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 5, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 6, 2003

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Last Updated

June 6, 2013

Status Verified

June 1, 2013

Enrollment Period

2 years

First QC Date

June 5, 2003

Last Update Submit

June 5, 2013

Conditions

Recurrent Non-small Cell Lung CancerStage IIIB Non-small Cell Lung CancerStage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST)

    From the start of treatment until disease progression/recurrence, assessed up to 5 years

Secondary Outcomes (4)

  • Time to progression

    Interval between start of treatment with erlotinib hydrochloride and celecoxib and the date on which progressive disease, assessed up to 5 years

  • Overall survival

    Up to 5 years

  • Relationship between measures of treatment efficacy and EGFR and COX-2 levels

    Up to 5 years

  • Toxicity as assessed by NCI Common Toxicity Criteria (CTC) version 2.0

    Up to 5 years

Study Arms (2)

Group I (erlotinib hydrochloride, celecoxib)

EXPERIMENTAL

Patients receive oral erlotinib once daily and oral celecoxib twice daily.

Drug: erlotinib hydrochlorideDrug: celecoxibOther: laboratory biomarker analysis

Group II (erlotinib hydrochloride)

EXPERIMENTAL

Patients receive erlotinib as in group 1.

Drug: erlotinib hydrochlorideOther: laboratory biomarker analysis

Interventions

erlotinib hydrochlorideDRUG

Given orally (PO)

Also known as: CP-358,774, erlotinib, OSI-774
Group I (erlotinib hydrochloride, celecoxib)Group II (erlotinib hydrochloride)
celecoxibDRUG

Given PO

Also known as: Celebrex, SC-58635
Group I (erlotinib hydrochloride, celecoxib)
laboratory biomarker analysisOTHER

Correlative studies

Group I (erlotinib hydrochloride, celecoxib)Group II (erlotinib hydrochloride)

Eligibility Criteria

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

You may qualify if:

  • Histologically or cytologically confirmed non-small cell lung cancer
  • Stage IIIB (malignant pleural effusion only) or IV
  • Recurrent disease that has progressed after 1 or 2 prior chemotherapy regimens (platinum- or nonplatinum-based)
  • At least 1 unidimensionally measurable lesion\*
  • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
  • Must have tissue specimen available for assays
  • No brain metastases
  • Performance status - ECOG 0-2
  • Performance status - Karnofsky 60-100%
  • More than 3 months
  • WBC at least 3,000/mm\^3
  • Absolute neutrophil count at least 1,500/mm\^3
  • Platelet count at least 100,000/mm\^3
  • Bilirubin normal
  • AST/ALT no greater than 2.5 times upper normal limit (ULN)
  • +58 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib HydrochlorideCelecoxib

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

QuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Philip Bonomi

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 5, 2003

First Posted

June 6, 2003

Study Start

January 1, 2004

Primary Completion

January 1, 2006

Last Updated

June 6, 2013

Record last verified: 2013-06

Locations

US(1)