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Phase I study of biweekly gemcitabine followed by oxaliplatin and simplified 48‐h infusion of fluorouracil/leucovorin for advanced pancreatic cancer
Author(s) -
CH’ANG HUIJU,
WANG CHUANCHENG,
CHENG ANNLII,
HSU CHIUN,
LU YENSHEN,
CHANG MINGCHU,
LIN JAWTOWN,
WANG HSIUPO,
SHIAH HERSHYONG,
LIU TSANGWU,
CHANG JANGYANG,
WHANGPENG JACQUELINE,
CHEN LITZONG
Publication year - 2006
Publication title -
journal of gastroenterology and hepatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.214
H-Index - 130
eISSN - 1440-1746
pISSN - 0815-9319
DOI - 10.1111/j.1440-1746.2005.04022.x
Subject(s) - oxaliplatin , medicine , gemcitabine , regimen , fluorouracil , neutropenia , pancreatic cancer , gastroenterology , phases of clinical research , chemotherapy , cancer , surgery , colorectal cancer
Objectives: To evaluate the feasibility and maximal tolerated dose (MTD) of oxaliplatin of a triplet regimen consisting of gemcitabine, oxaliplatin and infusional fluorouracil (5‐FU)/leucovorin (LV) (GOFL) for advanced pancreatic cancer. Patients and Methods: Patients with histologically proven metastatic or unresectable, locally advanced pancreatic adenocarcinoma were eligible to take part in the study. The treatment consisted of fixed‐rate infusion (10 mg/m 2 /minute) of 800 mg/m 2 gemcitabine followed by 2‐h infusion of oxaliplatin and then 48‐h infusion of 5‐FU/LV day 1 and day 15 every 4 weeks. The oxaliplatin would be evaluated at three dose levels, 65, 75 and 85 mg/m 2 . Results: A total of 15 patients were enrolled at three dose levels. Dose‐limiting toxicity of neutropenic fever and grade 4 thrombocytopenia occurred in one of each six patients at oxaliplatin dose level of 65 mg/m 2 and 85 mg/m 2 , respectively. The MTD of oxaliplatin for this combination was 85 mg/m 2 . After a median four cycles of treatment, grade 3/4 neutropenia occurred in 46.7% of patients and thrombocytopenia in 13.3%. Non‐hematological toxicities were generally of grade 1/2. Objective tumor response was observed in five patients (33.3%, 95% confidence interval, 6.3–60.4%). Conclusion: Biweekly GOFL is a feasible regimen for advanced pancreatic cancer. For further phase II studies, the recommended dose of oxaliplatin is 85 mg/m 2 .