Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00070057
First received: October 3, 2003
Last updated: September 12, 2014
Last verified: February 2013
  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.


Condition Intervention Phase
Stage I Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Drug: celecoxib
Procedure: therapeutic conventional surgery
Other: pharmacological study
Other: laboratory biomarker analysis
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory, Open-Label Phase I Pharmacodynamic Study of COX-2 Inhibition With Celecoxib (Celebrex) and Aromatase Activity in Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Change in aromatase activity levels [ Time Frame: From baseline to post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in cell proliferation via a marker Ki67 between treatment arms by immunohistochemistry [ Time Frame: From baseline to post-treatment ] [ Designated as safety issue: No ]
  • Correlation between aromatase activity and levels of COX 2 protein, HER 2/neu and ER status in surgical specimens [ Time Frame: At post-treatment/surgery ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At post-treatment/surgery ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: April 2003
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (celecoxib)
Patients receive oral celecoxib twice daily for 1-3 weeks (according to the duration between biopsy and surgery) in the absence of unacceptable toxicity.
Drug: celecoxib
Given orally
Other Names:
  • Celebrex
  • SC-58635
Procedure: therapeutic conventional surgery
Undergo surgery
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (high-dose celecoxib)
Patients receive a higher dose of oral celecoxib as in arm I.
Drug: celecoxib
Given orally
Other Names:
  • Celebrex
  • SC-58635
Procedure: therapeutic conventional surgery
Undergo surgery
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies
Active Comparator: Arm III (surgery)
Patients do not receive treatment. All patients undergo surgery.
Procedure: therapeutic conventional surgery
Undergo surgery
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Other: laboratory biomarker analysis
Correlative studies

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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: NCT00070057

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Investigators
Principal Investigator: Elisa Port Memorial Sloan-Kettering Cancer Center
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00070057     History of Changes
Other Study ID Numbers: NCI-2012-01441, NCI-2012-01441, CDR0000329919, MSKCC-03027, N01-CN-35112, N01CN35112, P30CA008748
Study First Received: October 3, 2003
Last Updated: September 12, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Celecoxib
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014