Phase I Clinical and Pharmacology Study of Topotecan Given Daily for 5 Consecutive Days to Patients With Advanced Solid Tumors, With Attempt at Dose Intensification Using Recombinant Granulocyte Colony-Stimulating Factor

Abstract

The doses of topotecan recommended for use in phase II clinical trials in solid tumors are 1.5 and 1.25 mg/m2 daily in previously untreated and previously treated patients, respectively. Based on observed rates of recovery from myelosuppression, treatment should be possible on a 21-day cycle. Dose intensification was not possible with the use of rG-CSF; however, rG-CSF may be a useful addition to the regimens of those few patients who experience either prolonged granulocytopenia or neutropenic sepsis or those who are not able to receive their second treatment cycle by day 21.