Anastrozole and ZD 1839 in Treating Postmenopausal Women With Metastatic Breast Cancer

February 19, 2013 updated by: The University of Texas Health Science Center at San Antonio

A Phase II And Biologic Correlative Study Investigating ARIMIDEX In Combination With IRESSA (ZD1839) In Post-Menopausal Patients With Estrogen Receptor-Positive Metastatic Breast Carcinoma Who Have Previously Failed Hormonal Therapy

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Anastrozole may fight breast cancer by blocking the production of estrogen by the tumor cells. Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of advanced solid tumors. Combining anastrozole with ZD 1839 may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining anastrozole with ZD 1839 in treating postmenopausal women who have metastatic breast cancer that has not responded to hormone therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the antitumor activity of anastrozole and ZD 1839, as measured by objective response (partial or complete) or stable disease at 6 months, in post-menopausal women with estrogen receptor-positive, hormone refractory, metastatic breast cancer.
  • Determine the progression-free and overall survival of patients treated with this regimen.
  • Determine the safety of this regimen in these patients.
  • Determine the pharmacokinetics of this regimen in these patients.
  • Correlate molecular markers with clinical benefit in patients treated with this regimen.

OUTLINE: This is an open-label, multicenter study.

Patients are stratified according to prior objective response to endocrine therapy (yes vs no).

Patients receive oral anastrozole once daily alone for 2 weeks. Patients then receive oral anastrozole and oral ZD 1839 once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients are followed at 1 month and then monthly thereafter.

PROJECTED ACCRUAL: A total of 36-78 patients (18-39 per stratum) will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • Cancer Therapy and Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer

    • Metastatic or locally advanced unresectable disease

  • At least 1 measurable target lesion that has not been irradiated

    • New lesions in a previously irradiated field allowed as sites of measurable disease
  • Progressive disease after more than 2 months of aromatase inhibitor therapy
  • No known CNS disease or unevaluated CNS symptoms suggestive of brain metastases

  • Hormone receptor status:

    • Estrogen receptor or progesterone receptor positive

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Post-menopausal by 1 of the following criteria:

    • Age 50 and over and has not menstruated during the past year or has castrate follicle-stimulating hormone (FSH) levels (greater than 40 IU/L)
    • Under age 50 and has castrate FSH levels
    • Received prior bilateral oophorectomy and has castrate FSH levels

Performance status

  • ECOG 0-2

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • ALT or AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)

Renal

  • Creatinine no greater than 1.5 times ULN

Cardiovascular

  • No history of congestive heart failure requiring therapy
  • No ventricular arrhythmia requiring therapy
  • No unstable angina pectoris
  • No myocardial infarction within the past 6 months

Other

  • Able to swallow oral medication
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No known malabsorption condition or other condition that would impair absorption of study drug
  • No active infection
  • No other concurrent medical condition that would preclude study
  • No known severe hypersensitivity to ZD 1839 or any excipients

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior chemotherapy except in adjuvant setting
  • No concurrent chemotherapy for breast cancer

Endocrine therapy

  • See Disease Characteristics
  • More than 30 days since other prior hormonal therapy (including hormone replacement therapy and megestrol)
  • Concurrent steroids for other reasons besides skin toxicity allowed
  • No other concurrent hormonal therapy (including megestrol) for breast cancer

Radiotherapy

  • See Disease Characteristics

Surgery

  • Recovered from prior oncologic or other major surgery
  • No concurrent ophthalmic surgery

Other

  • More than 30 days since prior anticancer therapy
  • More than 30 days since prior non-approved or investigational drugs
  • No prior epidermal growth factor receptor or HER2 blockers
  • No concurrent phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, Hypericum perforatum, or systemic retinoids
  • No other concurrent investigational therapy for breast cancer
  • Concurrent bisphosphonates for metastatic bone disease allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at San Antonio

Investigators

  • Study Chair: Eric K. Rowinsky, MD, Cancer Therapy and Research Center, Texas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Mita M, de Bono JS, Mita A, et al.: A phase II and biologic correlative study investigating anastrozole (A) in combination with geftinib (G) in post menopausal patients with estrogen receptor positive (ER) metastatic breast carcinoma (MBC) who have previously failed hormonal therapy. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-1117, 2005.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

November 12, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

February 21, 2013

Last Update Submitted That Met QC Criteria

February 19, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000257752
  • CTRC-IDD-0219
  • CTRC-IDD-1839US
  • CTRC-IDD-0228

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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