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Gemcitabine, 5-FU, and Cisplatin for Advanced Pancreatic and Biliary Cancers
NCT01661114Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2011
- Primary completion
- Dec 2014
- Countries
- 1
- Sponsor
- University of Michigan Rogel Cancer Center
- Modality
- Small Molecules
- Conditions
- pancreatic adenocarcinoma (PDAC)biliary tract cancer (BTC)
01
Overview
Phase 2, open-label, single-arm trial of gemcitabine, fluorouracil and cisplatin in pancreatic adenocarcinoma (PDAC) and biliary tract cancer (BTC), sponsored by University of Michigan Rogel Cancer Center. Primary endpoint: Partial Response Rate at 28 days. Started Jul 2011; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
Gemcitabine, 5-FU and Cisplatin
Gemcitabine, 5-FU and Cisplatin combination therapy
03
Who it enrols
Patients with metastatic pancreatic adenocarcinoma or biliary tract cancer, ECOG 0-1, adequate organ function, and max 1 prior cytotoxic regimen (no prior cisplatin).
04
Endpoints
Primary
Partial Response Rate
Secondary
Overall Survival
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