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| Name | Class |
|---|---|
| Ohio State University | OTHER |
| University of Texas Southwestern Medical Center | OTHER |
| Washington University School of Medicine | OTHER |
This is a Phase I study, which means we want to find out what effects, good and/or bad, this combination of drugs may have on the patient and the liver cancer at different dose levels. All patients will have an operation to remove tumors in the liver and may have a pump placed in their abdomen.
On this study, both drugs given have been used in other patients for treatment of cholangiocarcinoma and other gastrointestinal cancers. Both drugs are approved by the food and drug administration (FDA) for treatment of liver cancer, but the two drugs have only been combined in a few patients.
That means that in this trial we also want to find out if this combination is safe.
The study will also evaluate if this treatment works in delaying or stopping the cancer from coming back after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HAI with FLOXURIDINE & DEXAMETHASONE & GEMCITABINE | Experimental | This is an open-label single arm study. multi-institution phase I dose escalating trial of adjuvant HAIP FUDR and Gemcitabine chemotherapy after curative resection of ICC. Hepatectomy with or without bile duct reconstruction and pump placement are performed. The patients will start therapy 4 weeks postoperatively. They will receive HAI FUDR/Dex and systemic gemcitabine in the following dose escalation levels of gemcitabine. The dose of HAI FUDR will be fixed. A classic 3+3 cohort dose escalation scheme will be used to identify the MTD of the combination. Level 1: Systemic gemcitabine 650mg/m^2 Day 1 and 15 and HAI FUDR/Dex 0.12mg/kg/day Day 1-14 Level 2.Systemic gemcitabine 800mg/m^2 Day 1 and 15 HAI FUDR/Dex 0.12 mg/kg/day Day 1-14 Level 3. Systemic gemcitabine 1000mg/m^2 Day 1 and 15 HAI FUDR/Dex 0.12 mg/kg/day Day 1-14 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver resection and placement of hepatic artery infusion pump | Procedure |
| ||
| FLOXURIDINE |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Toxicity | All toxicities will be rated as per the NCI Common Toxicity Criteria (CTC AE version 4.0) except neurosensory and hepatic enzyme toxicities related to intrahepatic pump therapy. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence Free Survival | we will evaluate the recurrence-free survival of patients in this trial using Kaplan-Meier methods. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Cercek, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center at Basking Ridge | Basking Ridge | New Jersey | United States | |||
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| Drug |
|
| DEXAMETHASONE | Drug |
|
| GEMCITABINE | Drug |
|
| Memorial Sloan Kettering Cancer Center at Commack |
| Commack |
| New York |
| 11725 |
| United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Cancer Center at Mercy Medical Center | Rockville Centre | New York | 11570 | United States |
| Memorial Sloan Kettering Cancer Center Sleepy Hollow | Sleepy Hollow | New York | 10591 | United States |
| ID | Term |
|---|---|
| D018281 | Cholangiocarcinoma |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D006498 | Hepatectomy |
| D005467 | Floxuridine |
| D003907 | Dexamethasone |
| D000093542 | Gemcitabine |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003857 | Deoxyuridine |
| D014529 | Uridine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
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