NCT00075413

Brief 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.

Trial Health

10
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2004

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Last Updated

October 2, 2015

Status Verified

September 1, 2015

Enrollment Period

2.7 years

First QC Date

January 9, 2004

Last Update Submit

September 30, 2015

Conditions

Breast Cancer

Keywords

stage IIIB breast cancerstage IIIC breast cancerstage IV breast cancerrecurrent breast cancerstage IIIA breast cancer

Interventions

arsenic trioxideDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

ArsenicalsInorganic ChemicalsOxidesOxygen Compounds

Study Officials

  • Dennie V. Jones, MD

    University of Texas

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2004

First Posted

January 12, 2004

Study Start

November 1, 2002

Primary Completion

July 1, 2005

Last Updated

October 2, 2015

Record last verified: 2015-09