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Home > "P" Clinical Trials Conditions > Pyrazoloacridine in Treating Women With Refractory Metastatic Breast Cancer  Pyrazoloacridine in Treating Women With Refractory Metastatic Breast Cancer
Pyrazoloacridine in Treating Women With Refractory Metastatic Breast Cancer
For Condition: recurrent breast cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of pyrazoloacridine in treating women who have refractory metastatic breast cancer.
Details: OBJECTIVES: I. Determine the efficacy of pyrazoloacridine in patients with refractory breast cancer. II. Determine the toxic effects of pyrazoloacridine in these patients. PROTOCOL OUTLINE: Patients receive pyrazoloacridine IV over 3 hours. Treatment repeats every 21 days for 2-8 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed metastatic breast cancer - Bidimensionally measurable disease of any of the following types required: Bidimensionally measurable lung lesions on chest X-ray, CT scan, or MRI; Palpable and quantifiable lymph nodes at least 2 x 2 cm; Abdominal mass at least 2 x 2 cm quantifiable by CT scan; Bidimensionally measurable liver metastases at least 2 x 2 cm; Palpable hepatomegaly if liver edge is clearly defined and extends at least 5 cm below the costal margin of the xiphoid process - Unacceptable as measurable disease: Diffuse lung infiltration or unidimensionally measurable hilar lesions; Pelvic mass of indefinite dimension; Bone metastases; Pleural effusion or ascites - No brain metastases - Must have failed or progressed on prior therapy or relapsed less than 12 months after therapy discontinuation - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent biologic therapy - Chemotherapy: See Disease Characteristics; No more than 2 prior chemotherapy regimens for metastatic disease; One prior adjuvant chemotherapy regimen for metastatic disease allowed; At least 4 weeks since prior chemotherapy; No other concurrent chemotherapy - Endocrine therapy: One prior regimen of hormonal therapy for metastatic disease allowed; At least 3 weeks since prior hormonal therapy and recovered; No concurrent hormonal or corticosteroid therapy - Radiotherapy: At least 4 weeks since prior radiotherapy to less than 25% bone marrow; No concurrent radiotherapy - Surgery: At least 4 weeks since prior surgery and recovered; No concurrent surgery - Other: At least 4 weeks since any prior treatment directed at the tumor and recovered; No other concurrent anticancer or investigational therapy; No concurrent participation on another therapeutic clinical trial --Patient Characteristics-- - Age: 16 and over - Sex: Female - Menopausal status: Not specified - Performance status: SWOG 0-2 - Life expectancy: At least 6 months - Hematopoietic: Granulocyte count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: SGOT no greater than 2.5 times upper limit of normal; Bilirubin no greater than 1.5 mg/dL - Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min - Cardiovascular: No history of congestive heart failure, myocardial infarction within past 6 months, ventricular arrhythmia, or ischemic heart disease requiring medication; If necessary, ejection fraction at least 50% by MUGA - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No other prior malignancies in past 5 years other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; No other serious illnesses or active infections; No seizure disorder requiring anticonvulsant therapy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
EricKraut, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Grant/Riverside Methodist Hospitals
Columbus, Ohio, 43214
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210
United States
Mount Carmel
Columbus, Ohio, 43222
United States
Central Baptist Hospital
Lexington, Kentucky, 40503
United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29605
United States
Additional Information:
Study ID Numbers: CDR0000065670; OSU-9712,NCI-T96-0120
Study Start Date: July 1997
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003041
Other Recurrent Breast Cancer Studies:
1. Docetaxel and Trastuzumab With or Without Carboplatin in Treating Women With HER2-Positive Breast Cancer
2. Chemotherapy in Treating Women With Metastatic Breast Cancer
3. Letrozole With or Without CCI-779 in Treating Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
4. Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer
5. Biological Therapy in Treating Women With Stage IV Breast Cancer
Related Studies:
Other recurrent breast cancer Clinical Trials
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Pyrazoloacridine in Treating Women With Refractory Metastatic Breast Cancer
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