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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: April 11, 2013
Last verified: April 2013
History of Changes
  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:

Drug Information available for: Celecoxib
U.S. FDA Resources

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
Primary Completion Date: April 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
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
National Cancer Institute (NCI)
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, MSKCC-03027, CDR0000329919, N01CN35112
Study First Received: October 3, 2003
Last Updated: April 11, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

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

ClinicalTrials.gov processed this record on June 18, 2013