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

NCT ID: NCT00104767

Last Updated: 2015-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2015-10-31

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

celecoxib

Group Type: EXPERIMENTAL

celecoxib

Intervention Type: DRUG

Interventions

celecoxib

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Jonsson Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edward Garon, MD

Role: PRINCIPAL_INVESTIGATOR

Jonsson Comprehensive Cancer Center

Locations

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, United States

Countries

United States

Other Identifiers

UCLA-0407028-01

Identifier Type: -

Identifier Source: secondary_id

CDR0000415733

Identifier Type: -

Identifier Source: org_study_id

NCT00744783

Identifier Type: -

Identifier Source: nct_alias