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

Original Study ID : CDR0000415733

Secondary ID : UCLA-0407028-01

NCT ID : 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)

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.

Source : University of California, Los Angeles

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.

Overall Status : Recruiting

Start Date : February 2006

Official Title : Phase 1

Phase : Interventional

Study Design : Treatment

Enrollment : 24

Verification Date : March 2009

First Received Date : March 3, 2005

Trial Eligibility

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

Gender : Both

Minimum Age : 18 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : Jonsson Comprehensive Cancer Center at UCLA

Status : Recruiting

City : Los Angeles

State : California

Zip Code : 90095-1781

Country : United States

OutComes

Primary OutComes

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

Safety issue : No

Secondary OutComes

Measure : OBD necessary to decrease PBL FOXP3 levels at 1 week

Safety issue : No

Measure : Function of CD4+ and CD25+ T-regulatory cells at 1 week

Safety issue : No

Measure : Markers of cyclooxygenase-2 (COX-2) dependent gene expression before and after treatment at 1 week

Safety issue : No

Interventions

Type : Drug

Name : celecoxib

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