Clinical trial NCT00003041: Pyrazoloacridine in Treating Women With Refractory Metastatic Breast Cancer
Official title: Phase II Evaluation of Pyrazoloacridine (NSC #366140) in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: recurrent breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2004-04-23
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Central Baptist Hospital
state: Kentucky
city: Columbus
country: United States
facility: Arthur G. James Cancer Hospital - Ohio State University
state: Ohio
city: Columbus
country: United States
facility: Grant/Riverside Methodist Hospitals
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel
state: Ohio
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Eric H. Kraut, MD
role: STUDY_CHAIR
References: