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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00104767
First received: March 3, 2005
Last updated: September 8, 2014
Last verified: September 2014
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: 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)

Resource links provided by NLM:


Further study details as provided by Jonsson Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • OBD necessary to decrease PBL FOXP3 levels at 1 week [ Time Frame: 7 dayd ] [ Designated as safety issue: No ]
  • Function of CD4+ and CD25+ T-regulatory cells at 1 week [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Markers of cyclooxygenase-2 (COX-2) dependent gene expression before and after treatment at 1 week [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2009
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: celecoxib Drug: celecoxib

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Jonsson Comprehensive Cancer Center at UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Principal Investigator: Edward Garon, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00104767     History of Changes
Obsolete Identifiers: NCT00744783
Other Study ID Numbers: CDR0000415733, UCLA-0407028-01
Study First Received: March 3, 2005
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Jonsson Comprehensive Cancer Center:
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Celecoxib
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 01, 2014