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Clinical Trial Name - Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer

 
Original Study ID : CDR0000329919
Secondary ID : MSKCC-03027
NCT ID : NCT00070057
Brief Title : Celecoxib in Treating Postmenopausal Women Who Are Undergoing Surgery for Invasive Breast Cancer
Official Title : A Study of COX-2 Inhibition and Aromatase Activity in Breast Cancer
Brief Summary :

RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. 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.

Source : National Cancer Institute (NCI)
Detailed Description :

OBJECTIVES: Primary - Determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery. Secondary - Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase (COX)-2 and HER-2/neu and estrogen receptor status in these patients. - 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. - Determine whether any observed biological effect of this drug is dose-dependent in these patients. - 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.

Overall Status : Active, not recruiting
Start Date : April 2003
Official Title : Phase 1
Phase : Interventional
Study Design : Treatment, Randomized, Active Control
Verification Date : April 2005
First Received Date : October 3, 2003
Trial Eligibility
Criteria :
DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

Age

- Over 18

Sex

- Female

Menopausal status

- Postmenopausal as defined by at least 1 of the following:

- No menstrual period within the past 12 months

- Prior bilateral oophorectomy

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- No known liver disease

Renal

- No renal insufficiency

Cardiovascular

- No congestive heart failure

- No coronary artery disease

Gastrointestinal

- No history of documented peptic ulcer disease

- No gastritis

Other

- 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

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- More than 3 months since prior chemotherapy

Endocrine therapy

- 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

Radiotherapy

- Not specified

Surgery

- See Disease Characteristics

Other

- 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
Gender : Female
Minimum Age : 18 Years
Maximum Age : N/A
Healthy Volunteers : No
Facilities
Facility Name : Memorial Sloan-Kettering Cancer Center
City : New York
State : New York
Zip Code : 10021
Country : United States
Facility Name : New York Weill Cornell Cancer Center at Cornell University
City : New York
State : New York
Zip Code : 10021
Country : United States
Interventions
Type : Drug
Name : celecoxib
Type : Procedure
Name : conventional surgery
Type : Procedure
Name : neoadjuvant therapy
 
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