Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jonsson Comprehensive Cancer Center
With
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
Clareo Health | Celecoxib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
