NCT01339754

Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy

Salvage Therapy With Trabectedin in Metastatic Pancreatic Adenocarcinoma: A Single-Arm Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well trabectedin works in treating patients with metastatic pancreatic cancer after first-line chemotherapy.

Detailed description

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	trabectedin	1.3 mg/mq as a 3 hour continuous infusion every three weeks
DRUG	trabectedin	1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-12-01
• Completion: 2013-03-01
• First posted: 2011-04-21
• Last updated: 2014-08-11

Locations

1 site across 1 country: Italy