Purpose: This open-label, nonrandomized, phase II study was aimed at evaluating the efficacy and toxicity of trabectedin over a 3-hour intravenous infusion every 3 weeks in patients with pretreated advanced colorectal cancer.
Patients and methods: Twenty-one patients were enrolled: 5 patients (23.8%) were treated with 1650 microg/m(2), 10 patients (47.6%) with 1300 microg/m(2), and 6 patients (28.6%) with 1100 microg/m(2). Response to treatment was assessed according to World Health Organization criteria, and toxicities were graded according to National Cancer Institute Common Toxicity Criteria, version 2.0.
Results: The median number of treatment cycles per patient was 2 (range, 1-6 cycles). No objective responses were reported. Four patients (19%; 95% confidence interval [CI], 5.5%-41.9%) exhibited stable disease lasting for a median of 3.6 months (range, 2.4-4.9 months). The median time to progression was 1.5 months (95% CI, 1.3-1.6 months), and the median overall survival was 4.4 months (95% CI, 3-7.5 months; n=2 censored). The main grade 3/4 toxicities were transient asymptomatic transaminase increase (alanine aminotransferase, 66.7% of patients; aspartate aminotransferase, 57.1%) and neutropenia (42.8%). No toxic deaths were reported.
Conclusion: Trabectedin 1300 microg/m(2) given as a 3-hour intravenous infusion every 3 weeks was well tolerated but lacked activity in pretreated advanced-stage colorectal cancer. Therefore, further clinical trials with this trabectedin schedule as a single agent are not warranted.