Overview

Pyrazoloacridine in Treating Women With Metastatic Breast Cancer

Status:
Completed
Trial end date:
2001-01-01
Target enrollment:
0
Participant gender:
Female
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 with metastatic breast cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborator:
National Cancer Institute (NCI)
Treatments:
NSC 366140
Criteria
DISEASE CHARACTERISTICS: Histologically documented breast adenocarcinoma Clinical or
radiologic evidence of metastatic disease required Histologic confirmation recommended if
evidence is equivocal Bidimensionally measurable disease required, i.e.: Lesion with
clearly defined margins on physical exam or radiologic evaluation with 1 diameter greater
than 0.5 cm Lytic bone metastases only if measurable on bone x-ray/survey Lesion previously
irradiated only if subsequent measurable progression New measurable lesion in previously
irradiated field The following are not considered measurable: Unidimensionally measurable
lesions Palpable nodal disease not measurable on CT Masses with margins not clearly defined
Lesions with both diameters less than 0.5 cm Bone disease other than lytic bone disease
Pleural effusions or ascites Disease identified by bone scan only History of bilateral
breast cancer allowed No brain metastases CT required if clinically indicated No meningeal
carcinomatosis Hormone receptor status: Any status

PATIENT CHARACTERISTICS: Age: Over 18 Sex: Women only Menopausal status: Not specified
Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute
granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin
less than 2.0 mg/dL Renal: Creatinine less than 1.5 mg/dL Other: No second malignancy
within 5 years except: Adequately treated nonmelanomatous skin cancer Adequately treated
carcinoma in situ of the cervix Not pregnant or nursing Negative pregnancy test required of
premenopausal women Appropriate contraception required of fertile women Blood/body fluid
analyses to determine eligibility and physical exams for tumor measurement completed within
7 days prior to registration; imaging studies to evaluate and document measurable disease
completed within 4 weeks prior to registration

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1
prior chemotherapy for metastatic disease allowed At least 4 weeks since adjuvant
chemotherapy Endocrine therapy: Prior hormonal therapy allowed At least 4 weeks since
hormonal therapy for patients with partial or complete response to most recent maneuver
Radiotherapy: Prior radiotherapy for metastatic disease allowed At least 4 weeks since
radiotherapy and recovered Surgery: Not specified