Phase II of oral gimatecan in patients with recurrent epithelial ovarian, fallopian tube or peritoneal cancer, previously treated with platinum and taxanes

S Pecorelli, I Ray-Coquard, O Tredan, N Colombo, G Parma, G Tisi, D Katsaròs, C Lhommé, A A Lissoni, J B Vermorken, A du Bois, A Poveda, L Frigerio, P Barbieri, P Carminati, S Brienza, J P Guastalla, S Pecorelli, I Ray-Coquard, O Tredan, N Colombo, G Parma, G Tisi, D Katsaròs, C Lhommé, A A Lissoni, J B Vermorken, A du Bois, A Poveda, L Frigerio, P Barbieri, P Carminati, S Brienza, J P Guastalla

Abstract

Background: A prospective phase II study was conducted to evaluate the efficacy and toxicity of oral gimatecan in patients with recurrent epithelial ovarian, fallopian tube or peritoneal cancer.

Patients and methods: Patients had a maximum of three prior chemotherapy lines with no more than two prior platinum-containing regimens and a progression-free interval after the last dose of platinum <12 months. A total dose of 4 mg/m(2)/cycle (0.8 mg/m(2)/day from day 1 to day 5) was administered, repeated every 28 days.

Results: From June 2005 to December 2005, 69 assessable patients were enrolled. The best overall response to study treatment by combined CA-125 and RECIST criteria was partial response in 17 patients (24.6%) and disease stabilization in 22 patients (31.9%). The median time to progression and overall survival were 3.8 and 16.2 months, respectively. A total of 312 cycles were administered. Neutropenia grade 4 and thrombocytopenia grade 4 occurred in 17.4% and 7.2% of patients, respectively. Diarrhea grade 4 was never observed. Asthenia and fatigue were reported by 36.2% and 18.8% of patients, but were all grade 2 or less.

Conclusion: Gimatecan is a new active agent in previously treated ovarian cancer with myelosuppression as main toxicity.

Figures

Figure 1.
Figure 1.
Kaplan–Meier survival curves by progression-free interval (PFI).

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