NCT00693719

Irinotecan and Etoposide in Treating Patients With Recurrent, Locally Advanced, or Metastatic Breast Cancer

A Phase II Study: Irinotecan and Etoposide as Treatment for Refractory, Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Arizona · Academic / Other
• Sex: All
• Age: 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as irinotecan and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving irinotecan together with etoposide works in treating patients with recurrent, locally advanced, or metastatic breast cancer.

Detailed description

OBJECTIVES: Primary * To determine the response rate, as assessed by RECIST criteria, in patients with recurrent locally advanced or metastatic breast cancer treated with irinotecan hydrochloride and etoposide after prior exposure to anthracycline, taxane, and capecitabine therapy. Secondary * To determine the median time to progression in these patients. * To determine the response duration and survival in these patients. * To measure the type and rate of grade 3 or greater toxicity of this treatment regimen in these patients. OUTLINE: Patients receive irinotecan hydrochloride IV on days 1 and 15 and oral etoposide on days 1-14. Courses repeat every 28 days in the absence of disease progression or unaccepted toxicity. After completion of study therapy, patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Etoposide	50 mg PO x14 days followed by 2 weeks off, 28 day/Cycle
DRUG	Irinotecan hydrochloride	Irinotecan 100 mg/m2 IV days 1 and 15, 28 day/Cycle

Timeline

• Start date: 2007-08-01
• Primary completion: 2012-12-01
• Completion: 2013-05-01
• First posted: 2008-06-09
• Last updated: 2015-11-20
• Results posted: 2013-08-21

Locations

1 site across 1 country: United States