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

Sponsors and Collaborators:	University of California, Los Angeles Jonsson Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00104767

Purpose

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	Intervention	Phase
Lung Cancer	Drug: celecoxib	Phase I

MedlinePlus related topics: Ataxia Telangiectasia Cancer Lung Cancer

Drug Information available for: Celecoxib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	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)

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

Optimal biologic dose (OBD) necessary to decrease peripheral blood lymphocyte (PBL) CD4+ and CD25+ T-lymphocyte regulatory cells at 1 week [ Designated as safety issue: No ]

Secondary Outcome Measures:

OBD necessary to decrease PBL FOXP3 levels at 1 week [ Designated as safety issue: No ]
Function of CD4+ and CD25+ T-regulatory cells at 1 week [ Designated as safety issue: No ]
Markers of cyclooxygenase-2 (COX-2) dependent gene expression before and after treatment at 1 week [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	February 2006
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

Age: 18 and over
Performance status: ECOG 0-2
Life expectancy: Not specified
Hematopoietic: Not specified
Hepatic: Not specified
Renal: Creatinine ≤ 2 mg/dL
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No comorbid disease, psychiatric condition, chronic medical condition, or laboratory abnormality that would preclude study treatment or compliance with study requirements
- No hypersensitivity to celecoxib, sulfonamides, aspirin, other NSAIDs, or any study reagent
- No history of gastrointestinal ulceration, bleeding, or perforation

PRIOR CONCURRENT THERAPY:

Biologic therapy: Not specified
Chemotherapy: 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
Surgery: Not specified
Other:
- 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)
- No other concurrent cyclooxygenase-2 or -3 inhibitors
- No other concurrent NSAIDs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00104767

Locations

United States, California
Jonsson Comprehensive Cancer Center at UCLA	Recruiting
Los Angeles, California, United States, 90095-1781
Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center 888-798-0719

Sponsors and Collaborators

University of California, Los Angeles

Jonsson Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Edward Garon, MD

Jonsson Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	UCLA Jonsson Comprehensive Cancer Center ( Edward Garon, MD )
Study ID Numbers:	CDR0000415733, UCLA-0407028-01
Study First Received:	March 3, 2005
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00104767 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Thoracic Neoplasms
Celecoxib
Cyclooxygenase Inhibitors
Cyclooxygenase 2 Inhibitors
Recurrence
Carcinoma
Respiratory Tract Diseases
Analgesics, Non-Narcotic

Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Thoracic Neoplasms
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase 2 Inhibitors
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Respiratory Tract Neoplasms
Celecoxib

Neoplasms by Histologic Type
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Carcinoma
Neoplasms
Analgesics, Non-Narcotic
Lung Diseases
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009