Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer

September 30, 2015 updated by: The University of Texas Medical Branch, Galveston

A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast

RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well arsenic trioxide works in treating women with locally advanced or metastatic breast cancer.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Determine the safety and activity of arsenic trioxide in women with locally advanced or metastatic breast cancer.
  • Determine the qualitative and quantitative toxic effects of this drug in these patients.

Secondary

  • Determine the response, in terms of objective tumor response and response duration, in patients treated with this drug.
  • Determine the patterns of failure and survival in patients treated with this drug.

OUTLINE: This is a pilot study.

Patients receive arsenic trioxide IV over 1-2 hours on days 1-5 of week 1 and on days 1 and 5 of weeks 2-8 (for course 1 only). Beginning with course 2 and for all subsequent courses, patients receive arsenic trioxide on days 1 and 5 of weeks 1-8. Treatment repeats every 8 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Patients who have a complete response (CR) receive an additional course beyond documentation of CR. Patients who have a CR due to local consolidative therapy (e.g., surgery or radiotherapy) receive an additional 2 courses beyond CR.

Patients are followed for 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 9-24 months.

Study Type

Interventional

Phase

  • Phase 2

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 to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer, meeting 1 of the following criteria:

    • Locally advanced disease

      • Cannot be adequately treated by radiotherapy or surgery
    • Metastatic disease
  • Ineligible for OR received prior anthracycline- and/or taxane-based chemotherapy with subsequent disease progression
  • No uncontrolled Central Nervous System (CNS) metastases
  • Ineligible for treatment protocols of higher priority

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Sex

  • Female

Menopausal status

  • Not specified

Performance status

  • Eastern Cooperative Oncology Group (ECOG) 0-1 OR
  • Southwest Oncology Group (SWOG) 0-1 OR
  • Zubrod 0-1

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic

  • Bilirubin no greater than 1.5 times normal
  • Serum Glutamic Oxalacetic Transaminase (SGOT)/Serum Glutamic Pyruvic Transaminase (SGPT) no greater than 3 times normal

Renal

  • Creatinine no greater than 2.0 mg/dL
  • Calcium no greater than 12 mg/dL

Cardiovascular

  • Cardiac ejection fraction greater than 50%
  • No myocardial infarction or ischemia within the past 6 months
  • No uncontrolled clinically significant dysrhythmia

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • Electrolytes normal
  • Magnesium normal
  • No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
  • No prior or ongoing grade 2-4 peripheral neuropathy
  • No comorbid condition that would render the patient at high risk from study treatment complications

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent cytokine therapy

Chemotherapy

  • See Disease Characteristics
  • No more than 3 prior chemotherapy regimens for breast cancer
  • No other concurrent chemotherapy

Endocrine therapy

  • Not specified

Radiotherapy

  • More than 2 weeks since prior radiotherapy
  • No prior radiotherapy to an indicator lesion unless there is objective evidence of tumor growth in that lesion

  • No concurrent radiotherapy except for the following:

    • Palliative or emergent radiotherapy
    • Local consolidative radiotherapy

Surgery

  • More than 2 weeks since prior surgery
  • Concurrent local consolidative surgery allowed

Other

  • At least 4 weeks since prior antineoplastic agents for nonmalignant conditions (e.g., methotrexate for rheumatoid arthritis)
  • No concurrent antineoplastic agents for nonmalignant conditions
  • No concurrent participation in another treatment protocol
  • Concurrent local palliative therapy 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

Collaborators and Investigators

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

Sponsor

The University of Texas Medical Branch, Galveston

Investigators

  • Study Chair: Dennie V. Jones, MD, University of Texas

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

November 1, 2002

Primary Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

January 9, 2004

First Submitted That Met QC Criteria

January 11, 2004

First Posted (Estimate)

January 12, 2004

Study Record Updates

Last Update Posted (Estimate)

October 2, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000346365
  • UTMB-02403

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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