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Title: Phase I pharmacokinetic study of chronomodulated dose-intensified combination of capecitabine and oxaliplatin (XELOX) in metastatic colorectal cancer
Authors: Farid, M.
Chowbay, B.
Chen, X.
Tan, S.H. 
Ramasamy, S.
Koo, W.H.
Toh, H.C.
Choo, S.P.
Ong, S.Y.K.
Keywords: Chronomodulated
Colorectal cancer
Phase I
Issue Date: Jul-2012
Citation: Farid, M., Chowbay, B., Chen, X., Tan, S.H., Ramasamy, S., Koo, W.H., Toh, H.C., Choo, S.P., Ong, S.Y.K. (2012-07). Phase I pharmacokinetic study of chronomodulated dose-intensified combination of capecitabine and oxaliplatin (XELOX) in metastatic colorectal cancer. Cancer Chemotherapy and Pharmacology 70 (1) : 141-150. ScholarBank@NUS Repository.
Abstract: Purpose: To evaluate the maximum tolerated dose (MTD) and pharmacokinetic profile of a chronomodulated, dose-intensified regimen of capecitabine in combination with oxaliplatin (XELOX) in metastatic colorectal cancer (mCRC). Methods: Patients (N = 18) with 0 or 1 line of prior chemotherapy received oxaliplatin 100 mg/m 2 on day 1 from 1400 to 1800 hours with escalating dose levels of capecitabine (2,500, 3,000, 3,500, 4,000, 4,500, and 5,000 mg) once daily taken at 2400 hours on days 1-5. Each cycle lasted 14 days. Results: The MTD of capecitabine was 4,500 mg. Transaminitis and anemia were the commonest non-hematologic and hematologic toxicities, respectively. Toxicities were generally mild, with only five occurrences of grade 3 toxicity and none of grade 4. There were no dose-limiting toxicities, defined as specific grade 3 or 4 toxicities occurring in the first two cycles of treatment. The objective response rate was 33.3 %, and median overall survival was 16.3 months (95 % CI: 11.2-18.2 months). The maximum plasma concentration (C max) and area under plasma concentration-time curve from time 0 to infinity (AUC [0-∞]) of the capecitabine metabolites in our fixed-dosing chronomodulated regimen were comparable to values seen with comparably dose-intense regimens but associated with significantly reduced toxicity. Conclusions: Chronomodulated dose-intensified XELOX facilitates delivery of dose-intense treatment in mCRC with a favorable therapeutic index that is promising. © 2012 Springer-Verlag.
Source Title: Cancer Chemotherapy and Pharmacology
ISSN: 03445704
DOI: 10.1007/s00280-012-1895-x
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