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

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ClinicalTrials.gov Identifier: NCT00104767
Recruitment Status : Completed
First Posted : March 4, 2005
Last Update Posted : October 2, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: celecoxib Phase 1

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Trial to Evaluate Cyclooxygenase 2 Inhibitor-Mediated Modulation of T Regulatory Cells in Advanced Non-Small Cell Lung Cancer (NSCLC)
Study Start Date : January 2009
Primary Completion Date : October 2014
Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Celecoxib
U.S. FDA Resources

Arm Intervention/treatment
Experimental: celecoxib Drug: celecoxib

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00104767

United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Edward Garon, MD Jonsson Comprehensive Cancer Center

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00104767     History of Changes
Obsolete Identifiers: NCT00744783
Other Study ID Numbers: CDR0000415733
First Posted: March 4, 2005    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: October 2015

Keywords provided by Jonsson Comprehensive Cancer Center:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents