Phase II Study of Irinotecan Plus Capecitabine in Patients With Antracycline and Taxane Pretreated Metastatic Breast Cancer
This is a nonrandomized, open-label, phase II study of irinotecan plus capecitabine in
patients with metastatic breast cancer previously treated with anthracyclines and taxanes.
Up to 44 qualified patients will be enrolled according to the exact single stage design.
Irinotecan 90 mg/m2 intravenously for 90 minutes once a week for 2 weeks (Days 1 and 8)
followed by 1-week rest period. Capecitabine is administered orally at a dose of 1,000 mg/m2
twice daily (total daily dose 2,000 mg/m2) as an intermittent regimen in 3-week cycles (2
weeks of treatment followed by a 1-week rest period). For practical reasons, capecitabine
doses are rounded to the nearest dose that could be administered with a combination of
500-mg and 150-mg tablets of drug. Capecitabine is given approximately 12 hours apart and
taken orally with water within 30 minutes after ingestion of food (breakfast or dinner).
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the response rate of capecitabine and irinotecan combination therapy in patients with metastatic breast cancer
Jungsil Ro, M.D.
National Cancer Center
Korea: Food and Drug Administration