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

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ClinicalTrials.gov Identifier: NCT00075413
Recruitment Status : Withdrawn (Unable to identify qualified subjects willing to participate in this study)
First Posted : January 12, 2004
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
The University of Texas Medical Branch, Galveston

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: arsenic trioxide Phase 2

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  (Clinical Trial)
Actual Enrollment : 0 participants
Primary Purpose: Treatment
Official Title: A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast
Study Start Date : November 2002
Actual Primary Completion Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources





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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00075413


Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Investigators
Study Chair: Dennie V. Jones, MD University of Texas

Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT00075413     History of Changes
Other Study ID Numbers: CDR0000346365
UTMB-02403
First Posted: January 12, 2004    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: September 2015

Keywords provided by The University of Texas Medical Branch, Galveston:
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Arsenic trioxide
Antineoplastic Agents