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

The University of Texas Medical Branch, Galveston

Overview

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.

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

Purpose

TREATMENT

Conditions

Breast Cancer

Interventions

arsenic trioxideDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 120 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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