Phase II trial of nanoparticle albumin-bound paclitaxel as second-line chemotherapy for unresectable or recurrent gastric cancer.

This multicenter phase II study first investigated the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) when given every 3 weeks to patients with unresectable or recurrent gastric cancer who had received a prior round of fluoropyrimidine-containing chemotherapy. Patients with unresectable or recurrent gastric cancer who experienced progression despite fluoropyrimidine-containing treatment were studied. Nab-paclitaxel was given i.v. at 260 mg/m(2) on day 1 of each 21-day cycle without anti-allergic premedication until disease progression or study discontinuation. The primary endpoint was the overall response rate. The secondary endpoints were the disease control rate, progression-free survival, overall survival, and safety. From April 2008 to July 2010, 56 patients were enrolled, 55 patients received the study treatment, and 54 patients were evaluable for responses. According to an independent review committee, the overall response rate was 27.8% (15/54; 95% confidence interval [CI], 16.5-41.6) and the disease control rate was 59.3% (32/54; 95% CI, 45.0-72.4). One patient had a complete response. The median progression-free survival and overall survival were 2.9 months (95% CI, 2.4-3.6) and 9.2 months (95% CI, 6.9-11.4), respectively. The most common grade 3/4 toxicities were neutropenia (49.1%), leucopenia (20.0%), lymphopenia (10.9%), and peripheral sensory neuropathy (23.6%). There were no treatment-related deaths. Nab-paclitaxel, given every 3 weeks, showed promising activity against previously treated unresectable or recurrent gastric cancers, with well-tolerated toxicities. (Trial registration, ClinicalTrials.gov: NCT00661167).