Expired Study
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New York, New York 10065


Purpose:

This randomized phase I trial is studying the side effects of celecoxib in treating postmenopausal women with invasive breast cancer who are scheduled to undergo surgery at Memorial Sloan-Kettering Cancer Center. Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.


Study summary:

PRIMARY OBJECTIVES: I. Determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery. SECONDARY OBJECTIVES: I. Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase (COX)-2 and HER-2/neu and estrogen receptor status in these patients. II. Determine the effect of this drug on histology, Ki67, RNA expression profile by microarray analysis, PI3-K, AKT and ERK1/2 MAP kinase activities, and PGE_2 levels in these patients. III. Determine whether any observed biological effect of this drug is dose-dependent in these patients. IV. Identify collateral targets (COX-2-independent) of this drug in these patients. OUTLINE: This is a randomized study. Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity. Arm II: Patients receive a higher dose of oral celecoxib as in arm I. Arm III: Patients do not receive treatment. All patients undergo definitive surgery. PROJECTED ACCRUAL: A total of 75 patients (25 per treatment arm) will be accrued for this study within 2-3 years.


Criteria:

Inclusion Criteria: - Histologically confirmed invasive breast carcinoma - Tumor at least 1 cm by radiologic estimate or physical exam - No disease limited to ductal carcinoma in situ only - Planning to undergo surgery at Memorial Sloan-Kettering Cancer Center - Hormone receptor status: - Not specified - Female - Postmenopausal as defined by at least 1 of the following: - No menstrual period within the past 12 months - Prior bilateral oophorectomy - No known liver disease - No renal insufficiency - No congestive heart failure - No coronary artery disease - No history of documented peptic ulcer disease - No gastritis - No medical condition that would preclude definitive surgery - No allergy to NSAIDs or sulfa-containing drugs - No connective tissue diseases, including any of the following: - Systemic lupus erythematosus - Reynaud's disease - Scleroderma - More than 3 months since prior chemotherapy - More than 2 weeks since prior hormone replacement therapy - More than 2 weeks since prior tamoxifen - More than 2 weeks since prior aromatase inhibitors - More than 2 weeks since prior raloxifene - More than 2 weeks since prior steroids - More than 1 week since prior nonsteroidal anti-inflammatory drugs (NSAIDs) - More than 1 week since prior cyclooxygenase (COX)-2 inhibitors - No concurrent warfarin - No concurrent thiazide or loop diuretics - No concurrent COX-2 inhibitors - No concurrent NSAIDs


NCT ID:

NCT00070057


Primary Contact:

Principal Investigator
Elisa Port
Memorial Sloan Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10065
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 17, 2017

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