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

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
arsenic trioxide
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer, stage IIIA breast cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 9, 2004
    Last Updated
    September 30, 2015
    Sponsor
    The University of Texas Medical Branch, Galveston
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00075413
    Brief Title
    Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer
    Official Title
    A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Unable to identify qualified subjects willing to participate in this study
    Study Start Date
    November 2002 (undefined)
    Primary Completion Date
    July 2005 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Texas Medical Branch, Galveston

    4. Oversight

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer, stage IIIA breast cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    arsenic trioxide

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Dennie V. Jones, MD
    Organizational Affiliation
    University of Texas
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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

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