Clinical trial · Interventional

Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer

A Pilot Phase II Protocol Of Arsenic Trioxide (TRISENOX) In Subjects With Advanced Carcinoma Of The Breast

NCT00075413CI-TRIAL-00019322withdrawnPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Unable to identify qualified subjects willing to participate in this study

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
arsenic trioxide	Drug	Arsenic Trioxide	ALIAS

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.