Phase II Trial of Paclitaxel Poliglumex (CT-2103) in Pre- and Post-Menopausal Women on Hormonal Replacement Therapy with Non-Small Cell Lung Cancer

The Phase II trial investigated paclitaxel poliglumex (CT-2103) as a single-agent therapy in 29 women with advanced non-small cell lung cancer (NSCLC) who had high estradiol levels and were on hormonal replacement therapy. The study aimed to assess progression-free survival (PFS) and overall survival, with secondary endpoints including safety and response. Patients received CT-2103 every 21 days, with an average of 2.8 cycles. The median time to progression was 44 days, and median overall survival was 223 days. While 37.9% of patients had stable disease and 3.4% had a partial response, the treatment was well-tolerated with minor toxicities such as grade 1 and 2 peripheral neuropathy. Despite some positive preliminary results, the study concluded that further testing of this treatment strategy was not justified due to the PFS and overall survival outcomes.