Letrozole and Celecoxib in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: celecoxib (Drug); letrozole (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Cancer Institute of New Jersey Official(s) and/or principal investigator(s):
Antoinette R. Tan, MD, Study Chair, Affiliation: Cancer Institute of New Jersey
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.
Clinical Details
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 design: Treatment, Open Label
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School, New Brunswick, New Jersey 08903, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: March 2004
Last updated: May 23, 2008
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