Biweekly docetaxel in recurrent ovarian cancer: a phase I dose finding study

Abstract

Purpose

To determine the maximum tolerated dose of biweekly docetaxel in patients with recurrent ovarian cancer, aiming at 70 mg/m².

Methods

In this phase I trial, 8 patients were treated with biweekly docetaxel 50–65 mg/m². Dose-limiting toxicities were defined as any grade 3–4 non-hematological toxicity, prolonged (≥1 week) grade 4 neutropenia or platelet count <25 × 10⁹/L, any neutropenic sepsis or febrile neutropenia, or any grade 4 thrombocytopenia or grade 3 thrombocytopenia with bleeding.

Results

Two groups of 3 patients each were given docetaxel 50 and 60 mg/m², respectively, and 2 patients received 65 mg/m². A total of 43 cycles were given; 26% of these were delayed, while granulocyte colony stimulating factor (G-CSF) support was used in 33%. The main toxicity was neutropenia: at dose levels of 50, 60, and 65 mg/m², grade 3–4 neutropenia occurred in 2/3, 3/3 and 1/2 patients, respectively. One patient experienced febrile neutropenia. A dose reduction was needed in 6 out of 13 cycles at the 65 mg/m² dose level. The study had to be closed prematurely due to the frequent need for G-CSF support, precluding the exploration of the 70 mg/m² dose. Non-hematological toxicities were mild. One patient had a partial response and six patients showed a stable disease.

Conclusions

The maximum tolerated dose of biweekly docetaxel could not be determined in this study. It seems that increasing the dose beyond 60 mg/m² without a routine use of G-CSF is difficult.