Dose-finding phase I and pharmacokinetic study of capecitabine (Xeloda) in combination with epirubicin and cyclophosphamide (CEX) in patients with inoperable or metastatic breast cancer

Oncology
Shigehira SajiJunichi Sakamoto

Abstract

The present study aimed to identify the recommended dose (RD) of capecitabine, epirubicin and cyclophosphamide (CEX) combination treatment for inoperable or metastatic breast cancer and to assess response rate, tolerability and pharmacokinetics in Japanese patients. Patients received 3-week cycles of fixed-dose intravenous cyclophosphamide (600 mg/m(2), day 1), intravenous epirubicin (75-100 mg/m(2), day 1) and oral capecitabine (628-900 mg/m(2) twice daily, days 1-14). Dose escalation/deescalation decisions for consecutive cohorts were made using the continual reassessment method (CRM). RD was defined as dose level closest to that causing dose-limiting toxicity (DLT) in 33% of patients. Among the 17 patients enrolled, 3 experienced DLT (hand-foot syndrome, anorexia, mucositis; all grade 3) and 3 (18%) febrile neutropenia. Based on CRM calculation, mean DLT occurrence probabilities (90% confidence intervals in parentheses) for levels 2, 3 and 4 were 21% (8-42%), 35% (17-56%) and 56% (38-71%), respectively. Level 3 was thus chosen as the RD. Combination treatment did not affect pharmacokinetic parameters of capecitabine, epirubicin or their metabolites. Objective responses were achieved by 7 patients (41%), including partial res...Continue Reading

References

Oct 1, 1998·The New England Journal of Medicine·G N Hortobagyi
Dec 16, 1998·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·M MiwaH Ishitsuka
Mar 18, 1999·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·J L BlumT Griffin
Nov 24, 1999·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·M A Villalona-CaleroE K Rowinsky
Nov 18, 2000·Investigational New Drugs·H Ishitsuka
Apr 5, 2001·Clinical Pharmacokinetics·B ReignerE Weidekamm
Jun 18, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Joyce O'ShaughnessyRobert Leonard
May 24, 2003·European Journal of Cancer : Official Journal for European Organization for Research and Treatment of Cancer (EORTC) [and] European Association for Cancer Research (EACR)·H BonnefoiM Piccart
Jun 16, 2004·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·William J GradisharP Kelly Marcom
Sep 9, 2005·Annals of Oncology : Official Journal of the European Society for Medical Oncology·A GoldhirschUNKNOWN Panel members
Jun 30, 2006·Annals of Oncology : Official Journal of the European Society for Medical Oncology·E Ferrazzi, L Stievano
Aug 24, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Joanne L BlumJoyce A O'Shaughnessy
Dec 1, 2006·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Stephen E JonesLina Asmar
Dec 29, 2006·The New England Journal of Medicine·Charles E GeyerDavid Cameron

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Citations

Oct 1, 2013·The Breast : Official Journal of the European Society of Mastology·Robert S KerbelShan Man
Jul 2, 2014·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Alexia Iasonos, John O'Quigley
Feb 7, 2017·Journal of Biopharmaceutical Statistics·Cody ChiuzanShing M Lee
Jul 10, 2009·The Cochrane Database of Systematic Reviews·Anna Dorothea A D W WagnerSusanne Unverzagt

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