- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00101062
Letrozole and Celecoxib in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
Phase II Study of Letrozole (Femara) and Celecoxib (Celebrex) in Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer
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.
Study Overview
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08903
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Masking: NONE
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Antoinette R. Tan, MD, Rutgers Cancer Institute of New Jersey
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Cyclooxygenase 2 Inhibitors
- Letrozole
- Celecoxib
Other Study ID Numbers
- 040402-4671; CDR0000407502
- P30CA072720 (U.S. NIH Grant/Contract)
- CINJ-NJ1103
- CINJ-5076v3
- CINJ-040402
- UMDNJ-4761
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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