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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00075413
First received: January 9, 2004
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Breast Cancer
Drug: arsenic trioxide
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Enrollment: 0
Study Start Date: November 2002
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075413

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

Additional Information:
No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00075413     History of Changes
Other Study ID Numbers: CDR0000346365, UTMB-02403
Study First Received: January 9, 2004
Last Updated: May 22, 2013
Health Authority: United States: Federal Government

Keywords provided by The University of Texas, 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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014