Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin
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|ClinicalTrials.gov Identifier: NCT01434459|
Recruitment Status : Terminated (PI moved to different institution)
First Posted : September 15, 2011
Last Update Posted : May 4, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Neoplasms Cholangiocarcinoma||Drug: Gemcitabine with TheraSphere||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Gemcitabine With TheraSphere® (Yttrium-90) in Patients With Hepatic Tumors of Pancreatobiliary Origin|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||September 2014|
U.S. FDA Resources
|Experimental: Gemcitabine with TheraSphere||
Drug: Gemcitabine with TheraSphere
Gemcitabine dose will be escalated and combined with therasphere.
- The maximum tolerated dose of gemcitabine when given in combination with therasphere [ Time Frame: 28 days ]Patients will receive full dose therasphere. The gemcitabine dose will start out low and the dose will increase after first 3 patients if no significant side effects are observed. The investigators will continue to increase the dose of gemcitabine as long as the investigators do not observe side effects or until we reach full dose of gemcitabine.
- Toxicities (side effects) experienced by patients on the trial [ Time Frame: 90 days ]Any side effect experienced on the trial will be graded according to the grading system developed by the national cancer institute. The number of patients with each side effect will be calculated.
- Tumor response rate when treated with gemcitabine and Therasphere using CT scan and F18-FDG-PET scan . [ Time Frame: 78 days ]Patients will receive a PET CT prior to treatment and then another PET CT scan at completion day 78. Comparison of tumor size and uptake of FDG will be performed using standard RECIST criteria
- The progression free of patients treated on the trial [ Time Frame: 12 months ]The investigators will follow patients with serial cross sectional (CT or MRI) scans. If the tumor shows growth on the scan then the investigators will calculate the time it took for the tumor to grow.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434459
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Hyun Kevin Kim, MD||Emory University Winship Cancer Institute|
|Principal Investigator:||Bassel El-Rayes, MD||Emory University Winship Cancer Institute|