Nitrocamptothecin in Treating Patients With Locally Recurrent or 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.
|Study Design:||Primary Purpose: Treatment|
|Official Title:||Phase II Study of RFS 2000 (9-Nitro-Camptothecin, 9-NC) in Patients With Relapsed Metastatic Breast Cancer|
|Study Start Date:||September 1999|
|Study Completion Date:||April 2004|
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.