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Sponsored by: |
National Cancer Center, Korea |
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Information provided by: | National Cancer Center, Korea |
ClinicalTrials.gov Identifier: | NCT00532714 |
To evaluate the response rate of capecitabine and irinotecan combination therapy in patients with metastatic breast cancer
Condition | Intervention | Phase |
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Breast Cancer Metastatic |
Drug: Irinotecan plus capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Ironotecan Plus Capecitabine in Patients With Antracycline and Taxane Pretreated Metastatic Breast Cancer |
Estimated Enrollment: | 36 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | October 2008 |
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).
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jungsil Ro, M.D. | +82-31-920-1610 | jungsro@ncc.re.kr |
Korea, Republic of, Gyeonggi-do | |
National Cancer Center | Recruiting |
809 Madu1-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769 | |
Contact: Jungsil Ro, MD 82-31-920-1610 jungsro@ncc.re.kr |
Principal Investigator: | Jungsil Ro, M.D. | National Cancer Center |
Study ID Numbers: | NCCCTS-06-201 |
Study First Received: | September 19, 2007 |
Last Updated: | September 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00532714 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
Antimetabolites Capecitabine Skin Diseases Irinotecan |
Neoplasm Metastasis Breast Neoplasms Taxane Breast Diseases |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Breast Neoplasms Pharmacologic Actions |
Neoplasms Neoplastic Processes Neoplasms by Site Pathologic Processes Therapeutic Uses Neoplasm Metastasis Breast Diseases |