Phase I/II Study of Weekly Oraxol for the Second-Line Treatment of Patients With Metastatic or Recurrent Gastric Cancer

Title
Phase I/II Study of Weekly Oraxol for the Second-Line Treatment of Patients With Metastatic or Recurrent Gastric Cancer
Author(s)
이경희백영준[백영준]KEUN-WOOK LEE[KEUN-WOOK LEE]KYUNG-SANG YU,[KYUNG-SANG YU,]JIN-A JUNG[JIN-A JUNG]YOUNG IEE PARK[YOUNG IEE PARK]DAE YOUNG ZANG[DAE YOUNG ZANG]JINWON KIM[JINWON KIM]SEOCK-AH IM[SEOCK-AH IM]유경상[유경상]
Issue Date
201508
Publisher
ALPHAMED PRESS
Citation
ONCOLOGIST, v.20, no.8, pp.896 - 897
Abstract
Background. Oraxol consists of paclitaxel and HM30181A, a P-glycoprotein inhibitor, to increase the oral bioavailability of paclitaxel. This phase I/II study (HM-OXL-201) was conducted to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of Oraxol. In addition, we investigated the efficacy and safety of Oraxol as second-line chemotherapy for metastatic or recurrent gastric cancer (GC). Methods. In the phase I component, paclitaxel was orally administered at escalating doses (90, 120, or 150 mg/m(2) per day) with a fixed dose (15 mg/day) of HM30181A. Oraxol was administrated 6 times per cycle (days 1, 2, 8, 9, 15, and 16) every 4 weeks. In the phase II component, the efficacy and safety of Oraxol were evaluated. Results. In the phase I component, the MTD could not be determined. Based on toxicity and pharmacokinetic data, the RP2D of oral paclitaxel was determined to be 150 mg/m(2). In the phase II component, 4 of 43 patients (9.3%) achieved partial responses. Median progression-free survival and overall survival were 2.6 and 10.7 months, respectively. Toxicity profiles were favorable, and the most common drug-related adverse events (grade >= 3) were neutropenia and diarrhea. Conclusion. Oraxol exhibited modest efficacy and favorable toxicity profiles as second-line chemotherapy for GC.
URI
http://hdl.handle.net/YU.REPOSITORY/31293http://dx.doi.org/10.1634/theoncologist.2015-0202
ISSN
1083-7159
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의과대학 > 내과학교실 > Articles
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