NCT00002585

Pyrazoloacridine in Treating Women With Metastatic Breast Cancer

PHASE II CLINICAL EVALUATION OF PYRAZOLOACRIDINE IN PATIENTS WITH METASTATIC BREAST CANCER

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: I. Assess the efficacy of pyrazoloacridine (PZA) administered by 3-hour infusion in women with metastatic breast cancer. II. Assess the qualitative and quantitative toxicities of PZA on this schedule. III. Assess the response duration and survival of patients treated with this agent. OUTLINE: All patients receive intravenous pyrazoloacridine (PZA) every 3 weeks in the absence of progressive disease or unacceptable toxicity. Therapy continues in responding patients until 6 months after a complete response or for 1 year, whichever is shorter; stable patients receive a maximum of 4 courses. The dose is increased once for patients who experience minimal toxicity. Patients who fail PZA are encouraged to continue therapy with cyclophosphamide/doxorubicin/fluorouracil (CAF). All patients are followed for survival. Prophylactic granulocyte colony-stimulating factor is not permitted. PROJECTED ACCRUAL: Up to 20 patients will be accrued over 7-12 months. If no more than 1 response is seen in the first 12 evaluable patients, accrual will cease.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	pyrazoloacridine

Timeline

• Start date: 1994-02-01
• Primary completion: 1999-10-01
• Completion: 2001-01-01
• First posted: 2004-08-11
• Last updated: 2012-03-12

Locations

1 site across 1 country: United States