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/m(2) and oxaliplatin 85 mg/m(2)-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/m(2) and oxaliplatin 85 mg/m(2)-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/m(2) of pemetrexed and 85 mg/m(2) in patients without extensive prior therapy and 300 and 85 mg/m(2), 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.
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/m(2) and oxaliplatin 85 mg/m(2)-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/m(2) and oxaliplatin 85 mg/m(2)-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/m(2) of pemetrexed and 85 mg/m(2) in patients without extensive prior therapy and 300 and 85 mg/m(2), 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.
Authors: P Therasse; S G Arbuck; E A Eisenhauer; J Wanders; R S Kaplan; L Rubinstein; J Verweij; M Van Glabbeke; A T van Oosterom; M C Christian; S G Gwyther Journal: J Natl Cancer Inst Date: 2000-02-02 Impact factor: 13.506
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Authors: Giorgio V Scagliotti; Cornelius Kortsik; Graham G Dark; Allan Price; Christian Manegold; Rafael Rosell; Mary O'Brien; Patrick M Peterson; Daniel Castellano; Giovanni Selvaggi; Silvia Novello; Johannes Blatter; Louis Kayitalire; Lucio Crino; Luis Paz-Ares Journal: Clin Cancer Res Date: 2005-01-15 Impact factor: 12.531
Authors: D A Rinaldi; H A Burris; F A Dorr; J R Woodworth; J G Kuhn; J R Eckardt; G Rodriguez; S W Corso; S M Fields; C Langley Journal: J Clin Oncol Date: 1995-11 Impact factor: 44.544
Authors: Eric Raymond; Christophe Louvet; Christophe Tournigand; Anne Marie Coudray; Sandrine Faivre; Aimery De Gramont; Christian Gespach Journal: Int J Oncol Date: 2002-08 Impact factor: 5.650
Authors: X Pivot; E Raymond; B Laguerre; M Degardin; L Cals; J P Armand; J L Lefebvre; D Gedouin; V Ripoche; L Kayitalire; C Niyikiza; R Johnson; J Latz; M Schneider Journal: Br J Cancer Date: 2001-09-01 Impact factor: 7.640