A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast
18 Years
N/A
Female
Breast Cancer
Trial Information
A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Dennie V. Jones, MD
Investigator Role:
Study Chair
Investigator Affiliation:
University of Texas
Authority:
United States: Federal Government
Study ID:
CDR0000346365
NCT ID:
NCT00075413
Start Date:
November 2002
Completion Date:
Related Keywords:
- Breast Cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV breast cancer
- recurrent breast cancer
- stage IIIA breast cancer
- Breast Neoplasms
Name | Location |
|---|
