drugset / Trial / NCT02109341

Phase I/II Study to Evaluate Nab-paclitaxel in Substitution of CPT11 or Oxaliplatin in FOLFIRINOX Schedule as First Line Treatment in Metastatic Pancreatic Cancer

NCT02109341 ↗

Phase 1/2 Completed 148 enrolled Italian Oncology Group for Clinical Research
RandomizedParallel-groupOpen-labelTreatment

Summary

At this moment, FOLFIRINOX is the best treatment for selected patients (pts) with metastatic pancreatic cancer (mPC). Investigator would like to evaluate the substitution of CPT11 or Oxaliplatin in FOLFIRINOX schedule with Nab-paclitaxel (Nab-p) \[Nab-FOLFIRI and Nab-FOLFOX\]. Doses for Nab-FOLFIRI and Nab-FOLFOX will be determined by the phase I trial. One or both schedules will be evaluated in successive phase II part.

Timeline

Start
2014-02
Primary completion
2015-12
Completion
2016-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Paclitaxel Small molecule 90 mg/m2 —