Phase II Study of Irinotecan/Capecitabine in Patients With Antracycline/Taxane Pretreated MBC
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|ClinicalTrials.gov Identifier: NCT00532714|
Recruitment Status : Completed
First Posted : September 20, 2007
Last Update Posted : December 30, 2011
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Metastatic||Drug: Irinotecan plus capecitabine||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Irinotecan Plus Capecitabine in Patients With Antracycline and Taxane Pretreated Metastatic Breast Cancer|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||December 2011|
No Intervention: Irinotecan plus capecitabine
Irinotecan 80 mg/m2 (intravenously once a week for 2 weeks (Days 1 and 8) followed by 1-week rest period) Capecitabine (orally at a dose of 1,000 mg/m2 twice daily 3-week cycles (2 weeks of treatment followed by a 1-week rest period))
Drug: Irinotecan plus capecitabine
Irinotecan 80 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).
- To evaluate the response rate of capecitabine and irinotecan combination therapy in patients with metastatic breast cancer [ Time Frame: 2009 ]
- To investigate the toxicity profiles of capecitabine and irinotecan combination To determine time to progression and overall survival [ Time Frame: 2009 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532714
|Korea, Republic of|
|National Cancer Center|
|809 Madu1-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769|
|Principal Investigator:||Jungsil Ro, M.D.||National Cancer Center|