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Phase II Evaluation of Pyrazoloacridine (NSC #366140) in Patients With Metastatic Breast Cancer

Phase 2
16 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II Evaluation of Pyrazoloacridine (NSC #366140) in Patients With Metastatic Breast Cancer

OBJECTIVES: I. Determine the efficacy of pyrazoloacridine in patients with refractory breast
cancer. II. Determine the toxic effects of pyrazoloacridine in these patients.

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.

Inclusion 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

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

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Eric H. Kraut, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 1997

Completion Date:

January 2002

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • Breast Neoplasms



Arthur G. James Cancer Hospital - Ohio State University Columbus, Ohio  43210
Central Baptist Hospital Lexington, Kentucky  40503
Grant/Riverside Methodist Hospitals Columbus, Ohio  43214
Mount Carmel Columbus, Ohio  43222
Cancer Centers of the Carolinas Greenville, South Carolina  29605