Letrozole and Celecoxib in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer - Full Text View

Sponsor:	University of Medicine and Dentistry New Jersey
Collaborator:	National Cancer Institute (NCI)
Information provided by:	University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:	NCT00101062

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: celecoxib Drug: letrozole	Phase II

Study Type:	Interventional
Study Design:	Masking: Open Label Primary Purpose: Treatment
Official Title:	Phase II Study of Letrozole (Femara) and Celecoxib (Celebrex) in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Letrozole Celecoxib

U.S. FDA Resources

Further study details as provided by University of Medicine and Dentistry New Jersey:

Study Start Date:	January 2004
Study Completion Date:	December 2005
Primary Completion Date:	December 2005 (Final data collection date for primary outcome measure)

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.

Eligibility

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00101062

Locations

United States, New Jersey
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903

Sponsors and Collaborators

University of Medicine and Dentistry New Jersey

National Cancer Institute (NCI)

Investigators

Study Chair:

Antoinette R. Tan, MD

Cancer Institute of New Jersey

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Antionette Tan, MD, UMDNJ/CINJ
ClinicalTrials.gov Identifier:	NCT00101062 History of Changes
Other Study ID Numbers:	040402-4671; CDR0000407502, P30CA072720, CINJ-NJ1103, CINJ-5076v3, CINJ-040402, UMDNJ-4761
Study First Received:	January 7, 2005
Last Updated:	June 3, 2011
Health Authority:	United States: Federal Government

Keywords provided by University of Medicine and Dentistry New Jersey:

stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Celecoxib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Central Nervous System Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on February 09, 2012