Phase II Trial Evaluating OS With Therasphere® + 2nd-Line FOLFOX in Pancreatic Liver Mets

PHASE2CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

April 30, 2012

Primary Completion Date

February 29, 2016

Study Completion Date

March 31, 2016

Conditions
Liver CancerPancreatic Cancer
Interventions
DRUG

FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin)

The usual treatment if gemcitabine chemotherapy has failed is chemotherapy with a drug combination called FOLFOX (folinic acid, 5-FU and oxaliplatin) given through a vein every 2 weeks for 6-10 cycles. Participants will receive this treatment.

DEVICE

TheraSpheres

TheraSpheres are a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver. TheraSpheres have restricted approval from the United States Food and Drug Administration (FDA) for the treatment of hepatocellular liver cancer; but has not yet been approved for the treatment of pancreatic cancer that has spread to the liver.

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center and Research Institute, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

BTG International Inc.

OTHER

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER