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
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Paclitaxel | Small molecule | 90 mg/m2 | — |