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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Treatments: Arsenic Trioxide

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