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- Title
Phase I study of 3-weekly docetaxel, capecitabine and oxaliplatin combination chemotherapy in patients with previously untreated advanced gastric cancer.
- Authors
Sun Jim Sym; Min-Hee Ryu; Hye Jin Kang; Sung Sook Lee; Heung-Moon Chang; Jae Lyun Lee; Tae Won Kim; Jeong Hwan Yook; Sung Tae Oh; Byung Sik Kim; Yoon-Koo Kang
- Abstract
Adding docetaxel to cisplatin and 5-fluorouracil (5-FU) (DCF) significantly improved clinical efficacy in advanced gastric cancer (AGC). To further improve the efficacy and tolerability, we substituted oxaliplatin for cisplatin and capecitabine for 5-FU in the DCF regimen and performed a phase I study to determine the recommended dose (RD) and dose-limiting toxicity (DLT) of docetaxel, capecitabine and oxaliplatin (DXO) combination in patients with AGC. Previously untreated patients with histologically proven metastatic AGC and ECOG performance status 0–2 were enrolled. Docetaxel and oxaliplatin were administered i.v. on day 1. Capecitabine was administered orally bid on days 1–14. Each cycle was repeated every 3 weeks. DLTs were evaluated during the first two cycles of treatment. Twenty-one patients were enrolled: 15 patients in dose-escalation phase and 6 patients in the extension at the RD. Median age was 50 years (range 21–65 years). At dose level 3 (60 mg/m2 docetaxel, 1,000 mg/m2 capecitabine, 100 mg/m2 oxaliplatin), 1 diarrhea (DLT) was found among 6 patients while at dose level 4 (60 mg/m2 docetaxel, 800 mg/m2 capecitabine, 130 mg/m2 oxaliplatin), 2 DLTs (febrile neutropenia and diarrhea) were observed among 3 patients. Therefore, the dose level 3 was determined as RD. DLTs include grade 3 diarrhea and febrile neutropenia. Cumulative (all cycles) grade 3/4 toxicity included neutropenia (75%), leucopenia (50%), febrile neutropenia (25%), diarrhea (17%), and neuropathy (17%). Of 14 patients with measurable lesions, 11 achieved partial response and 3 showed stable disease. The RD of the DXO regimen in patients with AGC is capecitabine 1,000 mg/m2 twice daily on days 1–14, in combination with decetaxel 60 mg/m2 (day 1) and oxaliplatin 100 mg/m2 (day 1) repeated every 3 weeks. The DXO regimen seems to have promising activity and offers an easy alternative to DCF. The toxicities appear to be still substantial, but manageable.
- Publication
Cancer Chemotherapy & Pharmacology, 2010, Vol 66, Issue 2, p373
- ISSN
0344-5704
- Publication type
Academic Journal
- DOI
10.1007/s00280-009-1171-x