Phase I study of short-time oxaliplatin, capecitabine and epirubicin (EXE) as first line therapy in patients with non-resectable gastric cancer.
A phase I trial of short-time oxaliplatin (E), capecitabine (X) and epirubicin (E) for patients with metastatic gastric cancer was initiated to establish the recommended dose for further therapy with short-time EXE. Patients received out-patient therapy with a fixed dose of epirubicin 50 mg/m2 day 1; escalating doses of capecitabine (1,000 to 1,250 mg/m2/day continuously) and escalating doses of oxaliplatin (85 to 130 mg/m2 day 1 as a 30 minutes infusion). Cycles were repeated every 21 days for a maximum of 8 cycles. From June 2003 to June 2004, 31 patients were treated. Median age was 61 years (39-75 years), and median performance status was 0 (0-2). At level 3, one of six patients developed DLT and at dose level 4, two of six patients developed DLT (both patients had grade 4 hematological toxicities) and thus further dose escalation was not attempted. Median number of cycles was 6 (1-8), median survival was 9.2 months and median TTP was 7.5 months. A combination of epirubicin 50 mg/m2 day 1, capecitabine 1,000 mg/m2 continuously and oxaliplatin 130 mg/m2 day 1 each 3 weeks is an easily administered and well tolerated out-patient regimen for patients with non-resectable gastric cancer.
Dupont
Jeanette
J
Department of Oncology, Odense University Hospital, Odense, Denmark. dupont.jensen@ouh.fyns-amt.dk
Jensen
Helle A
HA
Jensen
Benny V
BV
Pfeiffer
Per
P
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D003718:Denmark; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D004943:Esophagogastric Junction / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D012720:Severity of Illness Index; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome
D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D015251:Epirubicin; D000069287:Capecitabine; D005472:Fluorouracil