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

Japanese Journal of Clinical Oncology

Volumn 34, Issue 2, 2004, Pages 104-106

  Morita, Satoshi ^a   Toi, Masakazu ^b   Kobayashi, Tadashi ^c   Ito, Yoshinori ^d   Hozumi, Yasuo ^e   Ohno, Shinji ^f   Iwata, Hiroji ^g   Sakamoto, Junichi ^a  

^a KYOTO UNIVERSITY   (Japan)

^b TOKYO METROPOLITAN KOMAGOME HOSPITAL   (Japan)

^c JIKEI UNIVERSITY SCHOOL OF MEDICINE   (Japan)

^d CANCER INSTITUTE HOSPITAL   (Japan)

^e JICHI MEDICAL UNIVERSITY   (Japan)

^f NATIONAL KYUSHU CANCER CENTER   (Japan)

^g AICHI CANCER CENTER HOSPITAL   (Japan)

Author keywords

Breast cancer; Capecitabine; Continual reassessment method; Phase I trial

Indexed keywords

ANTIBIOTIC AGENT; CAPECITABINE; CYCLOPHOSPHAMIDE; EPIRUBICIN; ANTINEOPLASTIC AGENT; DEOXYCYTIDINE; DRUG DERIVATIVE;

ADULT; AGED; ARTICLE; BREAST CANCER; CANCER COMBINATION CHEMOTHERAPY; CLINICAL TRIAL; DOSE CALCULATION; DOSE RESPONSE; FEBRILE NEUTROPENIA; HAND FOOT SYNDROME; HUMAN; INOPERABLE CANCER; LEUKOPENIA; MAXIMUM TOLERATED DOSE; NEUTROPENIA; OPEN STUDY; PHASE 1 CLINICAL TRIAL; RECURRENT CANCER; THROMBOCYTOPENIA; BREAST TUMOR; DRUG ADMINISTRATION; FEMALE; MIDDLE AGED; TUMOR RECURRENCE;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; CYCLOPHOSPHAMIDE; DEOXYCYTIDINE; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG ADMINISTRATION SCHEDULE; EPIRUBICIN; FEMALE; HUMANS; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL;

EID: 2342467486     PISSN: 03682811     EISSN: 14653621     Source Type: Journal    
DOI: 10.1093/jjco/hyh016     Document Type: Article

References (11)

1. Eisen T, Smith IE, Johnston S, Ellis PA, Prendiville J, Seymour MT, et al. Randomized phase II trial of infusional fluorouracil, epirubicin and cyclophosphamide versus infusional fluorouracil, epirubicin and cisplatin in patients with advanced breast cancer. J Clin Oncol 1998;16:1350-7.
2. Bonnefoi H, Biganzoli L, Cufer T, Mauriac L, Hamilton A, Schaefer P, et al. An EORTC phase I study of epirubicin in combination with fixed doses of cyclophosphamide and infusional 5-fu (CEF-infu) as primary treatment of large operable or locally advanced/inflammatory breast cancer. Breast Cancer Res Treat 2001;70:55-63.
3. Bonnefoi H, Biganzoli L, Mauriac L, Cufer T, Schaefer P, Atalay G, et al. An EORTC phase I study of capecitabine (Xeloda) in combination with fixed doses of cyclophosphamide and epirubicin (cex) as primary treatment for large operable or locally advanced/inflammatory breast cancer. Eur J Cancer 2003;39:277-83.
4. Miwa M, Ura M, Nishida M, Sawada N, Ishikawa T, Mori K, et al. Design of A novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissue. Eur J Cancer 1998;34:1274-81.
5. Blum JL, Jones SE, Buzdar AU, LoRusso PM, Kuter I, Vogel C, et al. Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 1999;17:485-93.
6. Blum JL, Dieras V, Lo Russo PM, Horton J, Rutman O, Buzdar A, et al. Multicenter, Phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patients. Cancer 2001;92:1759-68.
7. O'Quigley J, Pepe M, Fisher L. Continual reassessment method: A practical design for phase I clinical trials in cancer. Biometrics 1990;46:33-48.
8. Ishizuka N, Ohashi Y. The continual reassessment method and its applications: A Bayesian methodology for phase I cancer clinical trials. Stat Med 2001;20:2661-81.
9. Budman DR, et al. Preliminary studies of a novel oral fluoropyrimidine carbamate: Capecitabine. J Clin Oncol 1998;16:1795-802.
10. Mackean M, et al. Phase I and pharmacologic study of intermittent twice-daily oral therapy with capecitabine in patients, with advanced and/or metastatic cancer. J Clin Oncol 1998;16:2977-85.
11. O'Quigley J. Continual reassessment designs with early termination. Biostatistics 2002;3:87-99.