Phase II study of belotecan (CKD 602) as a single agent in patients with recurrent or progressive carcinoma of uterine cervix

The Phase II trial was conducted to evaluate the efficacy and toxicity of belotecan (CKD 602), a topoisomerase I inhibitor, in persistent or recurrent carcinoma of the cervix. Belotecan was administrated at 0.5 mg/m2/day for 5 consecutive days every 3-week cycle in patients with recurrent or progressive cervical carcinoma who were unsuitable candidates for curative treatment with surgery or radiotherapy. At the first stage of trial, a total of 16 patients were entered in the study. A median of three cycles were administrated per patient with a range of one to seven cycles. Fourteen of 16 patients (87.5%) had received radiotherapy or chemotherapy prior to the study. The most frequently severe adverse events were anemia and neutropenia. More than Grade 3 anemia and neutropenia were seen in 10 cycles (23.8%) and 6 cycles (14.3%) of 42 cycles, respectively. The incidence of non-hematologic toxicity was minimal. One patient died of treatment-related toxicities. There was no complete or partial response to belotecan. The median overall survival was 12.38 months (95% confidence interval, 9.71-15.04). Belotecan was not active in the treatment of recurrent or progressive cervical cancer as a single agent. ClinicalTrials.gov identifier: NCT00430144. (author)