Combination of Oxaliplatin Plus Irinotecan in Patients With Gastrointestinal Tumors: Results of Two Independent Phase I Studies With Pharmacokinetics

摘要: PURPOSE: Two phase I studies of the oxaliplatin and irinotecan combination were performed in advanced gastrointestinal cancer patients to characterize safety pharmacokinetics regimen. PATIENTS AND METHODS: Patients with a performance status (PS) ≤2 normal hematologic, hepatic, renal functions received (2-hour intravenous infusion) followed 1 hour later by administered over 30-minute period, every 3 weeks. Dose levels that explored ranged from 85 110 mg/m2 for 150 250 irinotecan. Plasma total ultrafiltrable platinum, irinotecan, SN-38, its glucuronide, SN-38G, determined. RESULTS: Thirty-nine carcinomas (24 colorectal [CRC], four pancreas cancer, gastric three hepatocarcinoma, other) 216 treatment cycles. Median age was 54 years (range, 21 72 years); 95% had PS 0 1; all but six fail...