Phase I/II Study of Weekly Oraxol for the Second‐Line Treatment of Patients With Metastatic or Recurrent Gastric Cancer |
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| Authors: | Dae Young Zang Young Iee Park Dong Bok Shin Jin Won Kim Seock‐Ah Im Sung Ae Koh Kyung‐Sang Yu Joo‐Youn Cho Jin‐A Jung Yung‐Jue Bang |
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| Institution: | 1. Department of Internal Medicine, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea;2. Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea;3. Department of Internal Medicine, Gachon University Gil Hospital, Incheon, Republic of Korea;4. Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea;5. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea;6. Department of Internal Medicine, Yeungnam University Hospital, Daegu, Republic of Korea;7. Department of Clinical Pharmacology and Therapeutics, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea;8. Clinical Research Team, Hanmi Pharmaceutical Co., Ltd., Seoul, Republic of Korea |
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| Abstract: | Lessons Learned- Oraxol, a novel oral formulation of paclitaxel, displayed modest efficacy as second-line chemotherapy for gastric cancer.
- Considering its favorable toxicity profiles, further studies are warranted in various solid tumors including gastric cancer.
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/m2 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/m2. 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. |
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