Abstract
Background. Both docetaxel (TXT) and irinotecan (CPT-11) are active chemotherapeutic agents for gastric cancer. We designed a biweekly administration regimen of TXT combined with CPT-11 for 4 weeks as one cycle in patients with inoperable or recurrent gastric cancer, and conducted a dose-escalation study.
Methods. Patients with histologically confirmed gastric cancer were treated with the regimen. The dosage levels of TXT and CPT-11 were as follows: level 1, 30 mg/m2 and 50 mg/m2; level 2, 35 and 50 mg/m2; level 3, 40 and 50 mg/m2; level 4, 40 and 60 mg/m2; and level 5, 50 and 60 mg/m2. The dose escalation was based on the dose-limiting toxicity (DLT) observed during the first cycle.
Results. Grade 4 neutropenia was observed at level 3, but no other DLT was observed at less than level 4 during the first cycle. However, three patients at level 3 could not continue treatment without a decrease in the dosage after the second cycle. Based on these results, level 2 was considered to be the clinically recommended dosages.
Conclusion. Biweekly TXT and CPT-11 was well tolerated. The recommended dosages of TXT and CPT-11 for a phase II trial are 35 mg/m2 and 50 mg/m2, respectively.
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Yoshioka, T., Sakata, Y., Terashima, M. et al. Biweekly administration regimen of docetaxel combined with CPT-11 in patients with inoperable or recurrent gastric cancer. Gastric Cancer 6, 153–158 (2003). https://doi.org/10.1007/s10120-003-0244-5
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DOI: https://doi.org/10.1007/s10120-003-0244-5