Breast CancerPhase 2NCT00075413
Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer
A Phase 2 study testing arsenic trioxide in people with Breast Cancer, run by The University of Texas Medical Branch, Galveston.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- arsenic trioxide
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Jul 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
About this study
Official title: A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- arsenic trioxide
- Keywords
- stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer, stage IIIA breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
arsenic trioxideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2004 (estimated)
- Study startNov 2002
- Primary completionJul 2005
Why it stopped: Unable to identify qualified subjects willing to participate in this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dennie V. Jones, MD, Study chair, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00075413
- Sponsor's protocol ID
- CDR0000346365
- Other IDs
- UTMB-02403
- Status last verified
- Sep 2015
- First submitted
- 9 Jan 2004
- Last updated
- 2 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast
- ClinicalTrials.gov ID
- NCT00075413
- Acronym / sponsor ID
- CDR0000346365
- Conditions
- Breast Cancer
- Keywords
- stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer, stage IIIA breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to identify qualified subjects willing to participate in this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Nov 2002
- Primary completion
- Jul 2005 (actual)
- First posted
- 12 Jan 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| arsenic trioxide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennie V. Jones, MD study chair
University of Texas
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing arsenic trioxide in people with Breast Cancer, run by The University of Texas Medical Branch, Galveston.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2015.