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

Primary Purpose

Lung Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
celecoxib
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jonsson Comprehensive Cancer Center at UCLA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

celecoxib

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

OBD necessary to decrease PBL FOXP3 levels at 1 week
Function of CD4+ and CD25+ T-regulatory cells at 1 week
Markers of cyclooxygenase-2 (COX-2) dependent gene expression before and after treatment at 1 week

Full Information

First Posted
March 3, 2005
Last Updated
October 1, 2015
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00104767
Brief Title
Celecoxib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
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 Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
celecoxib
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
celecoxib
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
OBD necessary to decrease PBL FOXP3 levels at 1 week
Time Frame
7 dayd
Title
Function of CD4+ and CD25+ T-regulatory cells at 1 week
Time Frame
7 days
Title
Markers of cyclooxygenase-2 (COX-2) dependent gene expression before and after treatment at 1 week
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Garon, MD
Organizational Affiliation
Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jonsson Comprehensive Cancer Center at UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095-1781
Country
United States

12. IPD Sharing Statement

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

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