Background: The objective of this study was to determine the maximum tolerated dose and dose-limiting toxicity (DLT) of carboplatin in combination with gemcitabine and irinotecan in patients with solid tumors.
Methods: Patients with solid tumors who were not candidates for standard chemotherapy received escalating doses of carboplatin, gemcitabine, and irinotecan.
Results: Twenty-eight patients were enrolled. Two of 4 patients who received carboplatin at an area under the curve (AUC) of 5 on Day 1 with gemcitabine 800 mg/m(2) and irinotecan 80 mg/m(2) on Days 1 and 8 developed DLT, along with 2 of 12 patients at the immediate-lower dose level: carboplatin at an AUC of 4 on Day 1 with gemcitabine 800 mg/m(2) and irinotecan 80 mg/m(2) on Days 1 and 8. In an attempt to improve drug delivery on Day 8, a different schedule was studied. Carboplatin at an AUC of 2, gemcitabine 800 mg/m(2), and irinotecan 60 mg/m(2), all given on Days 1 and 8, was explored in 12 patients. Two patients were unable to receive therapy on Day 8. Twenty-four patients developed grade 3 or 4 hematologic toxicity. Nonhematologic side effects were mostly mild and reversible with the exception of 1 patient, who developed acute liver failure after the fourth cycle of chemotherapy and died. Objective responses were observed in 7 patients, including 5 patients who had small cell and neuroendocrine carcinomas.
Conclusions: Carboplatin in combination with gemcitabine and irinotecan was feasible. However, compromise of single-agent doses of all 3 drugs was necessary because of toxicity. Additional studies are warranted in patients with small cell and high-grade neuroendocrine carcinomas.
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