Status:
WITHDRAWN
Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer
Lead Sponsor:
The University of Texas Medical Branch, Galveston
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-120 years
Phase:
PHASE2
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 ar...
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00075413
Start Date
November 1 2002
Last Update
October 2 2015
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