Phase II Study of Letrozole (Femara) and Celecoxib (Celebrex) in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer
18 Years
N/A
Female
Breast Cancer
Trial Information
Phase II Study of Letrozole (Femara) and Celecoxib (Celebrex) in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Antoinette R. Tan, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Cancer Institute of New Jersey
Authority:
United States: Federal Government
Study ID:
040402-4671; CDR0000407502
NCT ID:
NCT00101062
Start Date:
January 2004
Completion Date:
December 2005
Related Keywords:
- Breast Cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV breast cancer
- recurrent breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School | New Brunswick, New Jersey 08903 |
