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

Breast Cancer Clinical Trial

Official title:

A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00075413
• Other study ID #: CDR0000346365
• Secondary ID: UTMB-02403
• Status: Withdrawn
• Phase: Phase 2
• First received: January 9, 2004
• Last updated: September 30, 2015
• Start date: November 2002

Study information

• Verified date: September 2015
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• arsenic trioxide

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston