NCT00005817

Rebeccamycin Analogue in Treating Women With Stage IIIB or Stage IV Breast Cancer

A Randomized Phase 2 Study of Rebeccamycin Analog in Advanced Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized phase II trial to compare the effectiveness of two regimens of rebeccamycin analogue in treating women who have stage IIIB or stage IV breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. The best way to give rebeccamycin analog in breast cancer patients is not yet known

Detailed description

PRIMARY OBJECTIVES: I. To assess the activity of rebeccamycin analog as therapy for advanced breast cancer when administered in two different treatment schedules. SECONDARY OBJECTIVES: I. To assess the toxicity associated with administration of rebeccamycin analog therapy in women with advanced breast cancer. II. To evaluate topoisomerase I and II levels in human lymphocytes following treatment with rebeccamycin analog. OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive rebeccamycin analogue IV over 60 minutes on day 1. Arm II: Patients receive rebeccamycin analogue IV over 60 minutes on days 1-5. In all arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Conditions

• Male Breast Cancer
• Recurrent Breast Cancer
• Stage IIIB Breast Cancer
• Stage IV Breast Cancer

Interventions

Type	Name	Description
DRUG	becatecarin	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2000-03-01
• Primary completion: 2006-05-01
• First posted: 2003-01-27
• Last updated: 2013-02-01

Locations

1 site across 1 country: United States