ORLANDO—Interim results from a phase I/II clinical trial of patients with recurrent ovarian, fallopian tube, or peritoneal cancer show that polygutamate (PG)-paclitaxel (CT-2103, Xyotax) controlled disease in about half of the evaluable patients.
Less Toxic, More Selective
Paul Sabbatini, MD, of Memorial Sloan-Kettering Cancer Center, presented the interim findings in a poster at the 38th Annual Meeting of the American Society of Clinical Oncology (abstract 871). The investigators concluded that CT-2103, a less-toxic, more-selective form of paclitaxel(Drug information on paclitaxel) (Taxol), is active as a single agent in recurrent ovarian cancer and warrants further study.
"We have stable disease in patients who progressed on Taxol therapy," Dr. Sabbatini told ONI. He emphasized that most of the 89 patients in the trial had been heavily pretreated, failing as many as nine prior chemotherapy regimens.
Among 43 patients evaluable for response, CT-2103 was more effective in the 22 patients with platinum-sensitive disease. It produced a partial response in five of these patients (23%) and stable disease in eight (36%), providing disease control in 59% of patients. Of the 21 patients who were platinum resistant or refractory, one patient (5%) had a partial response, and eight (38%) had stable disease. In all, 51% of patients evaluated for response achieved disease control with the experimental agent.
Median progression-free survival at 9.5 months of follow-up was 4.0 months for platinum-sensitive patients and 3.1 months for platinum-resistant/refractory patients.
Cell Therapeutics Inc. in Seattle supported the ongoing phase I/II study. It is being conducted at seven cancer centers, and 29 of the 88 patients who began treatment were still receiving treatment at the time of the ASCO presentation.
