Phase I trial of pemetrexed plus oxaliplatin administered every other week in patients with metastatic cancer.
Phase I trial of pemetrexed plus oxaliplatin administered every other week in patients with metastatic cancer.
复制标题
培美曲塞加奥沙利铂对转移性癌症患者每隔一周给药一次的 I 期试验。
DOI：
10.1007/s10637-008-9133-4
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发表时间：
2008
影响因子：
3.4
通讯作者：
Rothenberg,MaceL
中科院分区：
文献类型：
--
作者：
Stover,DanielG;Lockhart,ACraig;Berlin,JordanD;Chan,Emily;Sandler,AlanB;Sosman,JefferyA;Middlebrook,Victoria;Nicol,Steven;Rothenberg,MaceL
Purpose: To identify the maximum tolerated dose (MTD) and describe dose-limiting toxicities (DLT) of pemetrexed and oxaliplatin given on a once-every-2-week schedule in patients with metastatic cancer.Patients and methods: Twenty-five patients were enrolled. Due to toxicities observed at the first dose level in unselected patients, a second MTD was determined in patients who had received zero to two prior chemotherapy regimens.Results: DLT was observed at dose level 1—pemetrexed 400 mg/m2and oxaliplatin 85 mg/m2—in the form of grade 3 fatigue in two of six patients. Enrollment was then limited to lightly pretreated patients and DLT was observed at dose level 2—pemetrexed 500 mg/m2and oxaliplatin 85 mg/m2—in the form of neutropenic fever in one of five patients. Complete response was confirmed in one patient (squamous cell carcinoma of the head and neck) and partial response was confirmed in three patients.Conclusions: The combination of pemetrexed and oxaliplatin can be safely administered at doses of 400 to 500 mg/m2of pemetrexed and 85 mg/m2in patients without extensive prior therapy and 300 and 85 mg/m2, respectively, every 2 weeks in patients with more extensive prior therapy. Based on promising results observed in this study, a phase II trial in patients with recurrent head and neck cancer has been initiated.
