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

Sponsor
National Cancer Institute (NCI) (NIH)
Overall Status
Completed
CT.gov ID
NCT00070057
Collaborator
(none)
75
Enrollment
1
Location
3
Arms
82.1
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: celecoxib
  • Procedure: therapeutic conventional surgery
  • Other: pharmacological study
  • Other: laboratory biomarker analysis
 Phase 1

Detailed Description

PRIMARY OBJECTIVES:
  1. Determine whether celecoxib suppresses aromatase activity in postmenopausal women with invasive breast cancer planning to undergo surgery.
SECONDARY OBJECTIVES:

  1. Correlate celecoxib-mediated inhibition of aromatase activity with levels of cyclooxygenase (COX)-2 and HER-2/neu and estrogen receptor status in these patients.

  2. 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.

  3. Determine whether any observed biological effect of this drug is dose-dependent in these patients.

  4. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Apr 1, 2003
Actual Primary Completion Date :
Feb 1, 2010
Actual Study Completion Date :
Feb 1, 2010

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • pharmacological studies

    • Other: laboratory biomarker analysis
    Correlative studies

    Outcome Measures

    Primary Outcome Measures

    1. Change in aromatase activity levels [From baseline to post-surgery]

    Secondary Outcome Measures

    1. Change in cell proliferation via a marker Ki67 between treatment arms by immunohistochemistry [From baseline to post-treatment]

    2. Correlation between aromatase activity and levels of COX 2 protein, HER 2/neu and ER status in surgical specimens [At post-treatment/surgery]

    3. 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 [At post-treatment/surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Memorial Sloan-Kettering Cancer Center New York New York United States 10065

    Sponsors and Collaborators

    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Elisa Port, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cancer Institute (NCI)
    ClinicalTrials.gov Identifier:
    NCT00070057
    Other Study ID Numbers:
    • NCI-2012-01441
    • NCI-2012-01441
    • CDR0000329919
    • MSKCC-03027
    • N01-CN-35112
    • P30CA008748
    • N01CN35112
    First Posted:
    Oct 7, 2003
    Last Update Posted:
    Dec 29, 2016
    Last Verified:
    Dec 1, 2016
    Additional relevant MeSH terms:
    Breast Neoplasms
    Celecoxib

    Study Results

    No Results Posted as of Dec 29, 2016