Objectives: This phase 2 study evaluated clinical efficacy, toxicity, and pharmacokinetics of combination gemcitabine ( GEM) and oxaliplatin (OXA) in patients with advanced pancreatic adenocarcinoma. Methods: Of 30 eligible patients, 20 had metastatic disease and 10 had nonmetastatic unresectable locally advanced disease. Gemcitabine 1000 mg/m(2) as a 10 mg/m(2)/ min intravenous infusion on day 1 and oxaliplatin 100 mg/m(2) as a 2-hour intravenous infusion on day 2 were administered every 2 weeks. Pharmacokinetics were evaluated in 11 patients by administering the 2 drugs in opposing sequences GEM-OXA ( GEM day 1, OXA day 2) and OXA-GEM ( OXA day 1, GEM day 2). Results: Of 30 patients evaluated, 9 had a partial response, 11 had disease stabilization, and 10 had disease progression. Median progression-free survival and overall survival were 5.5 and 9.5 months, respectively. The 1-year survival was 37% for all patients. This study revealed no significant pharmacokinetic interaction between the 2 drugs in the GEM-OXA or in the OXA-GEM sequence. Conclusions: The combination of GEM and OXA was well tolerated and showed a promising activity in patients with advanced pancreatic adenocarcinoma; no sequence-dependent pharmacokinetic interaction occurred when comparing the GEM-OXA versus the OXA-GEM sequence, with a 24-hour interval.
Gemcitabine and oxaliplatin in patients with pancreatic adenocarcinoma - Clinical and pharmacokinetic data
CATTEL, Luigi;MILLA, Paola;
2006-01-01
Abstract
Objectives: This phase 2 study evaluated clinical efficacy, toxicity, and pharmacokinetics of combination gemcitabine ( GEM) and oxaliplatin (OXA) in patients with advanced pancreatic adenocarcinoma. Methods: Of 30 eligible patients, 20 had metastatic disease and 10 had nonmetastatic unresectable locally advanced disease. Gemcitabine 1000 mg/m(2) as a 10 mg/m(2)/ min intravenous infusion on day 1 and oxaliplatin 100 mg/m(2) as a 2-hour intravenous infusion on day 2 were administered every 2 weeks. Pharmacokinetics were evaluated in 11 patients by administering the 2 drugs in opposing sequences GEM-OXA ( GEM day 1, OXA day 2) and OXA-GEM ( OXA day 1, GEM day 2). Results: Of 30 patients evaluated, 9 had a partial response, 11 had disease stabilization, and 10 had disease progression. Median progression-free survival and overall survival were 5.5 and 9.5 months, respectively. The 1-year survival was 37% for all patients. This study revealed no significant pharmacokinetic interaction between the 2 drugs in the GEM-OXA or in the OXA-GEM sequence. Conclusions: The combination of GEM and OXA was well tolerated and showed a promising activity in patients with advanced pancreatic adenocarcinoma; no sequence-dependent pharmacokinetic interaction occurred when comparing the GEM-OXA versus the OXA-GEM sequence, with a 24-hour interval.
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