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CompletedNCT00104767Updated Oct 2, 2015

Celecoxib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

A Phase 1 interventional study of celecoxib in Lung Cancer, sponsored by Jonsson Comprehensive Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-02.

Sponsored by Jonsson Comprehensive Cancer Center · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

OBJECTIVES:

Primary

  • Determine the optimal biologic dose (OBD) of celecoxib that is necessary to decrease peripheral blood lymphocyte CD4+ and CD25+ T-lymphocyte regulatory cells in patients with stage IIIB or IV non-small cell lung cancer.

Secondary

  • Determine the OBD of this drug that is necessary to decrease peripheral blood lymphocyte FOXP3 levels in these patients.

OUTLINE: This is a nonrandomized, dose-escalation study.

Patients receive oral celecoxib twice daily on days 1-7 in the absence of unacceptable toxicity.

Cohorts of 3 patients receive escalating doses of celecoxib until the optimal biologic dose (OBD) is determined. The OBD is defined as the lowest dose that results in the maximum decrease in peripheral blood lymphocyte CD4+ and CD25+ T-lymphocyte regulatory cells and FOXP3 levels where no dose-limiting toxicity occurs. An additional 15 patients are treated at the OBD.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

02

Conditions studied

  • Lung Cancer

Keywords

  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • recurrent non-small cell lung cancer
03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.

This study's enrollment of 7 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

Jonsson Comprehensive Cancer Center is the lead sponsor of 396 studies on the registry; 67 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 2 (5%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically confirmed non-small cell lung cancer
  • Stage IIIB or IV disease
  • Radiographically measurable disease
  • 18 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    celecoxib

    Drug: celecoxib

Interventions

  • Drugcelecoxib
06

What researchers measure

Primary outcomes

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

    Time frame: 7 days

Secondary outcomes

  1. OBD necessary to decrease PBL FOXP3 levels at 1 week

    Time frame: 7 dayd

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

    Time frame: 7 days

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

    Time frame: 7 days

07

Study locations

1 site
  • Jonsson Comprehensive Cancer Center at UCLA
    Los Angeles, California 90095-1781, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00104767
Lead sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Mar 4, 2005
Start date
Jan 2009
Primary completion
Oct 2014
Completion
Oct 2015
Last update
Oct 2, 2015

Study contacts

Edward Garon, MD
principal investigator · Jonsson Comprehensive Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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