Breast Cancer Clinical Trial
Official title:
Phase II Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) in Patients With Relapsed Metastatic Breast Cancer
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 nitrocamptothecin in treating patients
who have locally recurrent or metastatic breast cancer.
OBJECTIVES: I. Assess the toxicity and efficacy of nitrocamptothecin in patients with
locally recurrent or metastatic breast cancer. II. Determine the duration of response and
time to treatment failure in these patients with this treatment regimen. III. Correlate
serum levels of nitrocamptothecin and its lactone metabolite with response and toxicity in
these patients. IV. Correlate topoisomerase I and II levels with toxicity and response in
these patients.
OUTLINE: Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues
weekly for 8 weeks. Patients achieving complete or partial response or stable disease
continue therapy in the absence of disease progression or unacceptable toxicity. Patients
are followed every 3 months.
PROJECTED ACCRUAL: A total of 18-43 patients will be accrued for this study within 8-18
months.
;
Primary Purpose: Treatment
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