A phase I trial of paclitaxel and etoposide for metastatic or recurrent malignancies

Etoposide and paclitaxel (Taxol; Bristol-Myers Squibb Company, Princeton, NJ) each exhibit substantial activity against a variety of solid tumors. Etoposide promotes accumulation of cells in late S phase and in G2. Paclitaxel causes cell arrest in G2 and M. In this phase I trial, an empiric combination of a fixed dose of etoposide daily for 3 days followed by a 3-hour intravenous infusion of escalating doses of paclitaxel on day 4 is being tested. Cycles are repeated every 3 weeks. Dose level I, etoposide 100 mg/m2 intravenously days 1 to 3 and paclitaxel 80 mg/m2 intravenously day 4, was well tolerated. Dose level 2, with paclitaxel at 120 mg/m2, is near completion and appears tolerable as well. Further escalation of the paclitaxel dose is anticipated. Once the maximum tolerated dose of this combination is defined, growth factor will be added and further escalation of the paclitaxel dose will be attempted.