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

Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00104767
• Other study ID #: CDR0000415733
• Secondary ID: UCLA-0407028-01
• Status: Completed
• Phase: Phase 1
• First received: March 3, 2005
• Last updated: October 1, 2015
• Start date: January 2009
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00744783

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• celecoxib

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal biologic dose (OBD) necessary to decrease peripheral blood lymphocyte (PBL) CD4+ and CD25+ T-lymphocyte regulatory cells at 1 week		7 days	Yes
Secondary	OBD necessary to decrease PBL FOXP3 levels at 1 week		7 dayd	No
Secondary	Function of CD4+ and CD25+ T-regulatory cells at 1 week		7 days	No
Secondary	Markers of cyclooxygenase-2 (COX-2) dependent gene expression before and after treatment at 1 week		7 days	No