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Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer

Information source: National Cancer Institute (NCI)
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Intervention: celecoxib (Drug); therapeutic conventional surgery (Procedure); pharmacological study (Other); laboratory biomarker analysis (Other)

Phase: Phase 1

Status: Completed

Sponsored by: National Cancer Institute (NCI)

Official(s) and/or principal investigator(s):
Elisa Port, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

Summary

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.

Clinical Details

Official title: An Exploratory, Open-Label Phase I Pharmacodynamic Study of COX-2 Inhibition With Celecoxib (Celebrex) and Aromatase Activity in Breast Cancer

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in aromatase activity levels

Secondary outcome:

Change in cell proliferation via a marker Ki67 between treatment arms by immunohistochemistry

Correlation between aromatase activity and levels of COX 2 protein, HER 2/neu and ER status in surgical specimens

Effect of treatment vs. no treatment on gene expression (mRNA) profile by microarray, kinase activities (PI3, AKT and ERK1/2 MAP kinases) and PGE2 levels

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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

Locations and Contacts

Memorial Sloan-Kettering Cancer Center, New York, New York 10065, United States
Additional Information

Starting date: April 2003
Last updated: September 12, 2014

Page last updated: August 20, 2015

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