title: 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.
abstract: 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/m(2) 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/m(2) day 1 q3 weeks) and three levels of capecitabine (1255, 1657 and 1800 mg/m(2)/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.
authors.affiliation: Department of Epidemiological and Clinical Research Information Management, Kyoto University, Kyoto, Japan. smorita@pbh.med.kyoto-u.ac.jp
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Masakazu
authors.initials: M
authors.lastname: Toi
authors.forename: Tadashi
authors.initials: T
authors.lastname: Kobayashi
authors.forename: Yoshinori
authors.initials: Y
authors.lastname: Ito
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Hozumi
authors.forename: Shinji
authors.initials: S
authors.lastname: Ohno
authors.forename: Hiroji
authors.initials: H
authors.lastname: Iwata
authors.forename: Junichi
authors.initials: J
authors.lastname: Sakamoto
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D000069287:Capecitabine; D003520:Cyclophosphamide / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*
chemical_list: D003841:Deoxycytidine; D015251:Epirubicin; D000069287:Capecitabine; D003520:Cyclophosphamide; D005472:Fluorouracil