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A Phase I Study of Capecitabine Combined with CPT-11 in Metastatic Breast Cancer Pretreated with Anthracyclines and Taxanes.
- Source :
-
Oncology . Jun2014, Vol. 86 Issue 4, p206-211. 6p. 3 Charts. - Publication Year :
- 2014
-
Abstract
- Objective: A dose escalation study of biweekly irinotecan (CPT-11) combined with capecitabine was performed to determine the maximum tolerated dose (MTD) and recommended dose (RD) for metastatic breast cancer (MBC) previously treated with anthracyclines and taxanes. Methods: Escalating doses of CPT-11 (80-120 mg/m2) were administered on days 1 and 15. Capecitabine was administered at a fixed dose of 1,657 mg/m2/day for 21 consecutive days, followed by 7 days of rest. We treated 3-6 patients at a particular dose level until the MTD was determined. Results: Twenty patients were treated. The MTD was determined to be 100 mg/m2, as 3 of 6 patients developed dose-limiting toxicities, grade 3 leukopenia, neutropenia, photophobia, fatigue and diarrhea. The RD for the phase II study was thus determined to be 90 mg/m2. The response rate was 41.7%. Conclusions: Combination therapy with CPT-11 and capecitabine was well tolerated with a promising response rate for MBC that had been treated previously with anthracyclines and taxanes. A multi-center phase II study is warranted to evaluate the efficacy and safety of this combination therapy with pharmacokinetic assessment. © 2014 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]
- Subjects :
- *CELL receptors
*TUMOR markers
*ACADEMIC medical centers
*ANTHRACYCLINES
*ANTIMETABOLITES
*ANTINEOPLASTIC agents
*BREAST tumors
*COMBINATION drug therapy
*CONFIDENCE intervals
*DOSE-response relationship in biochemistry
*IMMUNOHISTOCHEMISTRY
*METASTASIS
*ONCOGENES
*DOCETAXEL
*DATA analysis software
*DESCRIPTIVE statistics
*IRINOTECAN
*PHARMACODYNAMICS
*THERAPEUTICS
Subjects
Details
- Language :
- English
- ISSN :
- 00302414
- Volume :
- 86
- Issue :
- 4
- Database :
- Academic Search Index
- Journal :
- Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 96653937
- Full Text :
- https://doi.org/10.1159/000358596