NCT00104767

Brief Summary

RATIONALE: Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also stimulate the immune system in different ways and stop tumor cells from growing. PURPOSE: This phase I trial is studying the side effects and best dose of celecoxib in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for phase_1 lung-cancer

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_1 lung-cancer

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

March 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2005

Completed
3.8 years until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 2, 2015

Status Verified

October 1, 2015

Enrollment Period

5.8 years

First QC Date

March 3, 2005

Last Update Submit

October 1, 2015

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancerstage IV non-small cell lung cancerrecurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

  • Optimal biologic dose (OBD) necessary to decrease peripheral blood lymphocyte (PBL) CD4+ and CD25+ T-lymphocyte regulatory cells at 1 week

    7 days

Secondary Outcomes (3)

  • OBD necessary to decrease PBL FOXP3 levels at 1 week

    7 dayd

  • Function of CD4+ and CD25+ T-regulatory cells at 1 week

    7 days

  • Markers of cyclooxygenase-2 (COX-2) dependent gene expression before and after treatment at 1 week

    7 days

Study Arms (1)

celecoxib

EXPERIMENTAL
Drug: celecoxib

Interventions

celecoxibDRUG
celecoxib

Eligibility Criteria

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

You may qualify if:

  • Histologically confirmed non-small cell lung cancer
  • Stage IIIB or IV disease
  • Radiographically measurable disease
  • and over
  • Performance status: ECOG 0-2
  • Renal: Creatinine ≤ 2 mg/dL
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • More than 4 weeks since prior chemotherapy
  • Endocrine therapy: More than 4 weeks since prior corticosteroids; No concurrent corticosteroids, including chronic corticosteroids, except for medically-indicated topical steroids
  • Radiotherapy: More than 4 weeks since prior radiotherapy
  • More than 4 weeks since other prior anticancer therapy
  • More than 4 weeks since prior non-cytotoxic investigational agents
  • At least 72 hours since prior nonsteroidal anti-inflammatory drugs (NSAIDs)

You may not qualify if:

  • pregnant or nursing
  • comorbid disease, psychiatric condition, chronic medical condition, or laboratory abnormality that would preclude study treatment or compliance with study requirements
  • hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or any study reagent
  • history of gastrointestinal ulceration, bleeding, or perforation
  • other concurrent cyclooxygenase-2 or -3 inhibitors
  • other concurrent NSAIDs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

Celecoxib

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 Compounds

Study Officials

  • Edward Garon, MD

    Jonsson Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2005

First Posted

March 4, 2005

Study Start

January 1, 2009

Primary Completion

October 1, 2014

Study Completion

October 1, 2015

Last Updated

October 2, 2015

Record last verified: 2015-10

Locations

US(1)