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

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• Status: Withdrawn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: Breast Cancer
• Intervention / Treatment: Drug: arsenic trioxide

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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Investigators: Study Chair: Dennie V. Jones, MD, University of Texas

Study record dates

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: stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer; stage IIIC breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Antineoplastic Agents; Arsenic Trioxide
• Other Study ID Numbers: CDR0000346365; UTMB-02403