NCT00653250

Brief Summary

RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This clinical trial is studying celecoxib in treating patients with stage I, stage II, or stage IIIA non-small cell lung cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Dec 2000

Longer than P75 for not_applicable 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

December 1, 2000

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2008

Completed
Last Updated

May 21, 2013

Status Verified

May 1, 2013

Enrollment Period

5.2 years

First QC Date

April 3, 2008

Last Update Submit

May 20, 2013

Conditions

Lung Cancer

Keywords

stage I non-small cell lung cancerstage II non-small cell lung cancerstage IIIA non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Correlation of expression of cyclo-oxygenase-2 (COX-2) activity with serum VEGF levels, tumor microvessel density score, tumor PEG2 and MMP levels, and urinary PGE-M

    COX-2 will be measured in pre-treatment tumor biopsy tissue as well as tumor microvessel density, MMP-2 and PGE2. VEGF will be measured in pre-treatment blood.

    Date of pretreatment biopsy surgery (tissue) and day 1 (blood)

Secondary Outcomes (1)

  • Effect of Celecoxib on COX-2 expression and microvascular density in tumor, PGE2 and MMP levels in tumor, serum VEGF levels and urinary PGE-M

    After day 5 of 5 days of treatment

Study Arms (1)

Therapeutic Intervention

EXPERIMENTAL

Correlative

Drug: celecoxibProcedure: biopsyProcedure: therapeutic conventional surgery

Interventions

celecoxibDRUG

400 mg P.O. BID for five days prior to obtaining second serum/urine collection (starting after initial biopsy, serum and urine collection)

Also known as: celebrex
Therapeutic Intervention
biopsyPROCEDURE

in patients with newly diagnosed NSCLC, a pretreatment excision of a small amount of tumor tissue

Therapeutic Intervention
therapeutic conventional surgeryPROCEDURE

surgery to remove the lung tumor

Also known as: tumor resection
Therapeutic Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Presumed histological or cytological diagnosis of non-small cell lung cancer * Diagnosis to be confirmed upon study entry to collect biopsy material for correlative studies * Stage I-IIIA disease PATIENT CHARACTERISTICS: * ECOG performance status of 0-2 * Serum creatinine ≤ 1.5 mg/dL * Granulocytes ≥ 1,500/mm\^3 * Platelets ≥ 100,000/mm\^3 * AST ≤ 3 times normal * Bilirubin ≤ 1.5 mg/dL * Not pregnant or nursing * Fertile patients must use effective contraception * No active unresolved infection PRIOR CONCURRENT THERAPY: * At least 7 days since prior and no concurrent non-steroidal anti-inflammatory agents or other cyclo-oxygenase-2 inhibitors * At least 7 days since prior parenteral antibiotics * No prior systemic chemotherapy or radiotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

CelecoxibBiopsyTransurethral Resection of Bladder

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative TechniquesUrologic Surgical ProceduresUrogenital Surgical Procedures

Study Officials

  • Vicki Keedy, MD

    Vanderbilt-Ingram Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine, Medical Oncologist

Study Record Dates

First Submitted

April 3, 2008

First Posted

April 4, 2008

Study Start

December 1, 2000

Primary Completion

March 1, 2006

Study Completion

January 1, 2008

Last Updated

May 21, 2013

Record last verified: 2013-05