Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer - Full Text View

Sponsor:	University of Texas
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00075413

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: arsenic trioxide	Phase II

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Arsenic Breast Cancer Cancer

Drug Information available for: Arsenic trioxide

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	30
Study Start Date:	November 2002
Primary Completion Date:	July 2005 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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 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

ECOG 0-1 OR
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
SGOT/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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00075413

Locations

United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555-0209

Sponsors and Collaborators

University of Texas

Investigators

Study Chair:

Dennie V. Jones, MD

University of Texas

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000346365, UTMB-02403
Study First Received:	January 9, 2004
Last Updated:	August 18, 2009
ClinicalTrials.gov Identifier:	NCT00075413 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Arsenic trioxide
Breast Neoplasms
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on November 27, 2009