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Japanese Journal of Clinical Oncology 34:104-106 (2004)
© 2004 Foundation for Promotion of Cancer Research

Application of a Continual Reassessment Method to a Phase I Clinical Trial of Capecitabine in Combination with Cyclophosphamide and Epirubicin (CEX) for Inoperable or Recurrent Breast Cancer

Satoshi Morita1, Masakazu Toi2, Tadashi Kobayashi3, Yoshinori Ito4, Yasuo Hozumi5, Shinji Ohno6, Hiroji Iwata7 and Junichi Sakamoto1,+

1 Department of Epidemiological and Clinical Research Information Management, Kyoto University, Kyoto, 2 Department of Surgery, Tokyo Metropolitan Komagome Hospital, Tokyo, 3 Department of Hematology and Oncology, Jikei University School of Medicine, Tokyo, 4 Department of Clinical Chemotherapy, Cancer Institute Hospital, Tokyo, 5 Department of Surgery, Jichi Medical School, Kawachi-gun, Tochigi, 6 Department of Breast Surgery, National Kyushu Cancer Center, Fukuoka and 7 Department of Breast Surgery, Aichi Cancer Center Hospital, Aichi-gun, Aichi, Japan

A phase I clinical trial was started in order to determine the recommended doses of capecitabine and epirubicin, when administered in combination with a fixed dose of cyclophosphamide (600 mg/m2 day 1 q3 weeks) in patients with inoperable or recurrent breast cancer. This study consists of five dose levels with combinations of three levels of epirubicin (75, 90 and 100 mg/m2 day 1 q3 weeks) and three levels of capecitabine (1255, 1657 and 1800 mg/m2/day consecutive administration for 2 weeks followed by 1 week of rest). Dose escalation and de-escalation decisions are based on a continual reassessment method (CRM). We conducted a survey of the clinical oncologists participating in this trial to determine the dose escalation/de-escalation rule, including a prior distribution for model parameters used in the CRM.

+ For reprints and all correspondence: Satoshi Morita, Department of Epidemiological and Clinical Research Information Management, Kyoto University Graduate School of Medicine, Yoshidakonoe-cho, Sakyo-ku, Kyoto 606-8501, Japan. E-mail: smorita{at}pbh.med.kyoto-u.ac.jp


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