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Letrozole and Celecoxib in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
celecoxib
letrozole
Sponsored by
University of Medicine and Dentistry of New Jersey
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the breast Locally advanced or metastatic disease Measurable disease No bone disease only No history of brain metastases unless controlled with radiotherapy or surgical resection for ≥ 6 months before study entry Hormone receptor status: Estrogen receptor- OR progesterone receptor-positive PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Postmenopausal, as defined by 1 of the following: Prior bilateral oophorectomy Prior bilateral ovarian irradiation No spontaneous menstrual bleeding within the past 12 months Age 55 and over AND prior hysterectomy without oophorectomy Age 54 and under AND prior hysterectomy without oophorectomy (or status of ovaries is unknown) AND documented follicle-stimulating hormone level in postmenopausal range Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic Granulocyte count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST and ALT ≤ 2.5 times ULN Renal Creatinine ≤ 1.5 times ULN Other No prior allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs No prior allergic reaction to sulfonamides No active peptic ulcer disease No active infection No other medical condition that would preclude study participation Able to swallow oral medication PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for metastatic or recurrent disease Endocrine therapy No prior endocrine therapy for metastatic disease Prior adjuvant tamoxifen allowed No prior aromatase inhibitors No prior hormonal therapy for recurrent disease No other concurrent hormonal therapy Radiotherapy See Disease Characteristics See Menopausal status No concurrent radiotherapy Surgery See Disease Characteristics See Menopausal status Other No concurrent fluconazole or lithium No concurrent aspirin, non-steroidal anti-inflammatory drugs, or other cyclooxygenase-2 inhibitors Concurrent chronic cardioprotective low-dose aspirin allowed No other concurrent investigational agents

Sites / Locations

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 7, 2005
Last Updated
June 3, 2011
Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00101062
Brief Title
Letrozole and Celecoxib in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Official Title
Phase II Study of Letrozole (Femara) and Celecoxib (Celebrex) in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Terminated
Why Stopped
study drug unavailable
Study Start Date
January 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Medicine and Dentistry of New Jersey
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving letrozole with celecoxib may kill more tumor cells. PURPOSE: This phase II trial is studying how well letrozole and celecoxib work in treating postmenopausal women with locally advanced or metastatic breast cancer.
Detailed Description
OBJECTIVES: Primary Determine the response rate in postmenopausal women with hormone receptor-positive locally advanced or metastatic adenocarcinoma of the breast treated with letrozole and celecoxib as first-line therapy. Secondary Determine the time to disease progression and overall survival of patients treated with this regimen. Determine the toxicity of this regimen in these patients. Compare cyclooxygenase activity in blood and tumor cells from these patients before and after treatment with this regimen. Determine the effect of this regimen on aromatase activity, tumor proliferation, and angiogenesis in tumor samples from these patients. OUTLINE: This is a multicenter study. Patients receive oral letrozole once daily and oral celecoxib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed for survival. PROJECTED ACCRUAL: A total of 45-72 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Type
Drug
Intervention Name(s)
letrozole

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed adenocarcinoma of the breast Locally advanced or metastatic disease Measurable disease No bone disease only No history of brain metastases unless controlled with radiotherapy or surgical resection for ≥ 6 months before study entry Hormone receptor status: Estrogen receptor- OR progesterone receptor-positive PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Postmenopausal, as defined by 1 of the following: Prior bilateral oophorectomy Prior bilateral ovarian irradiation No spontaneous menstrual bleeding within the past 12 months Age 55 and over AND prior hysterectomy without oophorectomy Age 54 and under AND prior hysterectomy without oophorectomy (or status of ovaries is unknown) AND documented follicle-stimulating hormone level in postmenopausal range Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic Granulocyte count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) AST and ALT ≤ 2.5 times ULN Renal Creatinine ≤ 1.5 times ULN Other No prior allergic reaction attributed to compounds of similar chemical or biologic composition to study drugs No prior allergic reaction to sulfonamides No active peptic ulcer disease No active infection No other medical condition that would preclude study participation Able to swallow oral medication PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for metastatic or recurrent disease Endocrine therapy No prior endocrine therapy for metastatic disease Prior adjuvant tamoxifen allowed No prior aromatase inhibitors No prior hormonal therapy for recurrent disease No other concurrent hormonal therapy Radiotherapy See Disease Characteristics See Menopausal status No concurrent radiotherapy Surgery See Disease Characteristics See Menopausal status Other No concurrent fluconazole or lithium No concurrent aspirin, non-steroidal anti-inflammatory drugs, or other cyclooxygenase-2 inhibitors Concurrent chronic cardioprotective low-dose aspirin allowed No other concurrent investigational agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoinette R. Tan, MD
Organizational Affiliation
Rutgers Cancer Institute of New Jersey
Official's Role
Study Chair
Facility Information:
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.gov/ct2/show/NCT00101062
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

Letrozole and Celecoxib in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer

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