Capecitabine, an Oral Fluoropyrimidine Carbamate With Substantial Activity in Advanced Colorectal Cancer: Results of a Randomized Phase II Study

作者: Eric Van Cutsem , Michael Findlay , Bruno Osterwalder , Walter Kocha , David Dalley

DOI: 10.1200/JCO.2000.18.6.1337

关键词: Confidence intervalOral administrationRegimenGastroenterologyCarcinomaSurgeryInternal medicineChemotherapyCapecitabineRectumPhases of clinical researchMedicine

摘要: PURPOSE: To evaluate in patients with advanced colorectal cancer (CRC) three treatment regimens of oral capecitabine order to select the most appropriate regimen for testing phase III. PATIENTS AND METHODS: Three schedules were evaluated a randomized II design: arm A, 1,331 mg/m2/d bid continuously; B, 2,510 intermittently (2 weeks on/1 week off); and C, 1,657 plus leucovorin 60 mg/d off). RESULTS: One hundred nine randomized; 39 assessable efficacy 34 35 C. Patient characteristics balanced arms. Confirmed tumor responses (partial response [PR] + complete [CR]) reported eight two CRs (21%; 95% confidence interval [CI], 9% 36%) one CR (24%; CI, 11% 41%) (23%; 10% 40%) Median times progression (TTP) i...

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