Trabectedin in Treating Patients With Metastatic Pancreatic Cancer After First-Line Chemotherapy (PACT-18)
Recruitment status was Active, not recruiting
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Salvage Therapy With Trabectedin in Metastatic Pancreatic Adenocarcinoma: A Single-Arm Phase II Trial|
- Progression-free survival (PFS) rate at 6 months [ Time Frame: every 9 weeks ] [ Designated as safety issue: No ]CT scan
- Safety profile [ Time Frame: every 3 weeks ] [ Designated as safety issue: Yes ]outpatient visit, laboratory findings
- Response rate and response duration [ Time Frame: every 2 months ] [ Designated as safety issue: No ]CT scan
- Overall survival [ Time Frame: every 3 weeks during therapy, every 2-3 months thereafter ] [ Designated as safety issue: No ]outpatient visit, phone interview
- PFS rate at 9 and 18 weeks [ Time Frame: every 9 weeks ] [ Designated as safety issue: No ]CT scan
- Identify biomarkers predictive for resistance or sensitivity to trabectedin [ Time Frame: at trial start ] [ Designated as safety issue: No ]tissue, blood, serum collection
- Impact of pharmacogenomic and pharmacokinetic profile on anti-tumor activity [ Time Frame: based on a pre-definid sample collection schedule ] [ Designated as safety issue: No ]blood samples
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01339754
|Istituto Scientifico H. San Raffaele|
|Milan, Italy, 20132|
|Principal Investigator:||Michele Reni, MD||Istituto Scientifico H. San Raffaele|