Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy
- Registration Number
- NCT01339754
- Lead Sponsor
- IRCCS San Raffaele
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description trabectedin trabectedin 1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) rate at 6 months every 9 weeks CT scan
- Secondary Outcome Measures
Name Time Method Response rate and response duration every 2 months CT scan
PFS rate at 9 and 18 weeks every 9 weeks CT scan
Overall survival every 3 weeks during therapy, every 2-3 months thereafter outpatient visit, phone interview
Identify biomarkers predictive for resistance or sensitivity to trabectedin at trial start tissue, blood, serum collection
Safety profile every 3 weeks outpatient visit, laboratory findings
Impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity based on a pre-definid sample collection schedule blood samples
Trial Locations
- Locations (1)
Istituto Scientifico H. San Raffaele
🇮🇹Milan, Italy