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

This study has been terminated.
(study drug unavailable)
Sponsor:
Collaborator:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00101062
First received: January 7, 2005
Last updated: June 3, 2011
Last verified: June 2011
  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 2

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:


Further study details as provided by Rutgers, The State University of 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 of New Jersey
Investigators
Study Chair: Antoinette R. Tan, MD Rutgers Cancer Institute of New Jersey
  More Information

Additional Information:
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 Rutgers, The State University of 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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Celecoxib
Letrozole
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antineoplastic Agents
Antirheumatic Agents
Aromatase Inhibitors
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014