|
Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer Clinical research trials and Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer. Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "A" Clinical Trials Conditions > Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer  Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer
Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer,stage 3B breast cancer,stage 3A breast cancer,stage 3C breast cancer
Status: Recruiting
Sponsor(s): University of Texas ,
Synopsis: 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: Phase II trial to study the effectiveness of arsenic trioxide in treating women who have locally advanced or metastatic breast cancer.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DennieJones, Study Chair, University of Texas
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0565
United States
Recruiting Dennie Jones 409-772-1165
Additional Information:
Study ID Numbers: CDR0000346365; UTMB-02403
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00075413
Other Stage 3c Breast Cancer Studies:
1. Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
2. Vaccine Therapy With Either Neoadjuvant or Adjuvant Chemotherapy and Adjuvant Radiation Therapy in Treating Women With p53-Overexpressing Stage II or Stage III Breast Cancer
3. Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
4. Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer
5. Erlotinib in Treating Women With Locally Advanced or Metastatic Breast Cancer
Related Studies:
Other stage 3C breast cancer Clinical Trials
Other Texas Clinical Trials
Other Galveston Clinical Trials
Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer
|
|
|
|
|
|
|
|
