Clinical trialPhase 1Terminated
Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin
Phase I Trial of Gemcitabine With TheraSphere® (Yttrium-90) in Patients With Hepatic Tumors of Pancreatobiliary Origin
- Outcome
- Stopped earlyPI moved to different institution (Other)
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- September 2011
- Expected end
- September 2014
- Enrollment
- 9 participants
- Sites
- 1
- Primary outcomes
- The maximum tolerated dose of gemcitabine when given in combination with therasphere
- Sponsor
- Other
- Results posted
- No
- Last update
- 4 May 2015
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Brief summary public domain (ClinicalTrials.gov)
Therasphere is a form of treatment that has been designed to selectively deliver radiation to the cancer within the patient's liver. This form of treatment has been used in a number of clinical trials and has been approved for use in the treatment of liver cancer. The investigators want to test the safety of using Gemcitabine (a chemotherapy drug) with TheraSphere (radioactive beads that are injected directly into the blood vessel supplying the tumor in the liver) in patients with advanced pancreatobiliary tumors such as pancreatic cancer or cholangiocarcinoma (bile duct tumors) involving the liver.
Detailed description public domain (ClinicalTrials.gov)
Patients with liver predominant cholangiocarcinoma or pancreatic cancer will be considered for the trial. The patients wre being treated in groups of thre patients. Each three patients receive a pre-specified dose of gemcitabine with full dose radioembolization using theraspheres. If no significant side effects are observed then three additional three patients will be treated with a higher dose of gemcitabine. The purpose to identify the highest dose of gemcitabine that can be safely combined with theraspheres.