Salvage Therapy With Trabectedin in Metastatic Pancreatic Adenocarcinoma: A Single-Arm Phase II Trial
OBJECTIVES:
Primary
- To assess the therapeutic activity of trabectedin, in terms of progression-free
survival (PFS) rate at 6 months, in patients with metastatic pancreatic adenocarcinoma
progressed after gemcitabine-containing first-line chemotherapy.
Secondary
- To assess the safety profile of this drug.
- To assess the response rate and response duration.
- To assess the overall survival of these patients.
- To assess the PFS rate at 9 and 18 weeks.
- To perform blood, plasma, and tumor tissue sampling for biological studies, in order to
identify biomarkers predictive for resistance or sensitivity to trabectedin, and to
characterize the impact of pharmacogenomic and pharmacokinetic profile on anti-tumor
activity in translational research studies.
OUTLINE: Patients receive trabectedin IV over 3 hours on day 1. Treatment repeats every 3
weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity.
Blood samples and tumor tissue are analyzed for identifying biological markers predictive
for resistance to treatment and pharmacogenomic and pharmacokinetic profiling on anti-tumor
activity in translational research studies.
After completion of study treatment, patients are followed up periodically.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival (PFS) rate at 6 months
CT scan
every 9 weeks
No
Michele Reni, MD
Principal Investigator
Istituto Scientifico H. San Raffaele
Italy: Ministry of Health
CDR0000698981
NCT01339754
February 2011
December 2012
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