BILIARY TRACT: METASTATIC: 1st Line: SWOG S1815

A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers

Title
SWOG S1815 (Biliary Tract)
Study Title

A Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab-Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers

Site Link
Malignancy
Biliary Tract, cholangiocarcinoma, gallbladder cancer, bile duct cancer
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
1st Line
Investigational Agent
nab-paclitaxel
Drug Class
taxane
PI
Axel Grothey, MD
Sponsor
Southwest Oncology Group (SWOG)
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Histologically confirmed intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer
  • Must have metastatic or unresectable disease and no prior therapy for metastatic disease
  • Does not need to be measurable disease
  • No ampullary cancer
  • No adjuvant therapy within 6 months prior to registration
  • ECOG PS 0-1
  • No other prior malignancy within 2 years
Objective
  • Primary
    • OS
  • Secondary
    • PFS
    • ORR
    • DCR
    • Safety
    • CA19-9 levels
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
biliary carcinoma
Dosing Frequency
Control Agents
Study Protocol
Randomized
Yes
X