Study of Gemcitabine With TheraSphere® (Yttrium-90)in Patients With Hepatic Tumors of Pancreatobiliary Origin
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.
Drug: Gemcitabine with TheraSphere
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Trial of Gemcitabine With TheraSphere® (Yttrium-90) in Patients With Hepatic Tumors of Pancreatobiliary Origin|
- The maximum tolerated dose of gemcitabine when given in combination with therasphere [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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.
|Study Start Date:||September 2011|
|Study Completion Date:||September 2014|
|Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
|Experimental: Gemcitabine with TheraSphere||
Drug: Gemcitabine with TheraSphere
Gemcitabine dose will be escalated and combined with therasphere.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|