PURPOSE: To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of the combination of weekly oxaliplatin x 4, weekly irinotecan x 4 and capecitabine Monday through Friday for 4 weeks of every 6 week cycle in patients with solid tumors; to determine the pharmacokinetic profile of these agents in this combination; to observe patients for clinical anti-tumor response. METHODS: Twenty-two patients with metastatic solid tumors received oxaliplatin 60 mg/m(2) weekly x 4, irinotecan beginning at a dose of 40 mg/m(2) weekly x 4, and capecitabine Monday through Friday for 4 weeks of every 6 week cycle, initially at 1,000 mg twice daily (bid). RESULTS: The MTD was oxaliplatin 60 mg/m(2) weekly x 4, irinotecan 50 mg/m(2) weekly x 4 and capecitabine 450 mg bid Monday through Friday for 4 weeks of every 6 week cycle. One of six patients at this dose level developed DLT of nausea, vomiting, and diarrhea. Among patients treated with a constant capecitabine dose of 450 mg bid, there was a higher mean AUC of 5-FU in women than in men (mean +/- SD: 892 +/- 287 nM h vs. 537 +/- 182 nM h; Mann-Whitney two-tailed, P = 0.02). There was one complete response in a patient with gastric cancer. CONCLUSION: The novel schedule of weekly oxaliplatin, weekly irinotecan, and capecitabine Monday through Friday, all administered for 4 weeks of every 6 week cycle, evaluated in this phase I trial is well-tolerated and demonstrated activity in a patient with gastric cancer.
PURPOSE: To determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of the combination of weekly oxaliplatin x 4, weekly irinotecan x 4 and capecitabine Monday through Friday for 4 weeks of every 6 week cycle in patients with solid tumors; to determine the pharmacokinetic profile of these agents in this combination; to observe patients for clinical anti-tumor response. METHODS: Twenty-two patients with metastatic solid tumors received oxaliplatin 60 mg/m(2) weekly x 4, irinotecan beginning at a dose of 40 mg/m(2) weekly x 4, and capecitabine Monday through Friday for 4 weeks of every 6 week cycle, initially at 1,000 mg twice daily (bid). RESULTS: The MTD was oxaliplatin 60 mg/m(2) weekly x 4, irinotecan 50 mg/m(2) weekly x 4 and capecitabine 450 mg bid Monday through Friday for 4 weeks of every 6 week cycle. One of six patients at this dose level developed DLT of nausea, vomiting, and diarrhea. Among patients treated with a constant capecitabine dose of 450 mg bid, there was a higher mean AUC of 5-FU in women than in men (mean +/- SD: 892 +/- 287 nM h vs. 537 +/- 182 nM h; Mann-Whitney two-tailed, P = 0.02). There was one complete response in a patient with gastric cancer. CONCLUSION: The novel schedule of weekly oxaliplatin, weekly irinotecan, and capecitabine Monday through Friday, all administered for 4 weeks of every 6 week cycle, evaluated in this phase I trial is well-tolerated and demonstrated activity in a patient with gastric cancer.
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Authors: Jeff A Sloan; Richard M Goldberg; Daniel J Sargent; Delfino Vargas-Chanes; Suresh Nair; Steven S Cha; Paul J Novotny; Michael A Poon; Michael J O'Connell; Charles L Loprinzi Journal: J Clin Oncol Date: 2002-03-15 Impact factor: 44.544
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Authors: Joanna M Brell; Smitha S Krishnamurthi; Milind Javle; Joel Saltzman; Ira Wollner; Robert Pelley; Afshin Dowlati; Belagodu N Kantharaj; Mark D Schluchter; Linda Rath; S Percy Ivy; Scot C Remick Journal: Cancer Chemother Pharmacol Date: 2008-08-01 Impact factor: 3.333