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NCT01938729 · ClinicalTrials.gov registry record · Phase 1
Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma
A Phase 1 study of Intrahepatic Cholangiocarcinoma and Peripheral Cholangiocarcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 5
- Study locations
NCT01938729: Completed Phase 1 study of Intrahepatic Cholangiocarcinoma and Peripheral Cholangiocarcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01938729 is a Phase 1 study of Intrahepatic Cholangiocarcinoma and Peripheral Cholangiocarcinoma that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 8 participants, below the 135-participant average among 17 other Intrahepatic Cholangiocarcinoma trials with a reported enrollment target (94% lower). The trial reports 5 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01938729, a Phase 1 study of Intrahepatic Cholangiocarcinoma and Peripheral Cholangiocarcinoma, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Liver resection and placement of hepatic artery infusion pump
- DRUG FLOXURIDINE
- DRUG DEXAMETHASONE
- DRUG GEMCITABINE
Study Locations (5)
New York
- Memorial Sloan Kettering Cancer Center at Commack - Commack
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Cancer Center at Mercy Medical Center - Rockville Centre
- Memorial Sloan Kettering Cancer Center Sleepy Hollow - Sleepy Hollow
New Jersey
- Memorial Sloan Kettering Cancer Center at Basking Ridge - Basking Ridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2013-09-05 |
| Est. Completion | 2020-09-10 |
| Phase | Phase 1 |
What the finished NCT01938729 record still lists
NCT01938729 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 135-participant average among 17 other Intrahepatic Cholangiocarcinoma trials with a reported enrollment target (94% lower).
The record links to 4 conditions, with Intrahepatic Cholangiocarcinoma appearing as the primary indexed condition, and to 4 interventions - of which Liver resection and placement of hepatic artery infusion pump is the first listed.
NCT01938729 lists 5 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT01938729 about?
NCT01938729 is a clinical study titled "Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Gemcitabine as Adjuvant Treatment After Resection of Intrahepatic Cholangiocarcinoma". 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 ...
What is the current status of trial NCT01938729?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2013-09-05. Estimated completion is 2020-09-10.
What conditions does trial NCT01938729 study?
This clinical trial studies the following conditions: Intrahepatic Cholangiocarcinoma, Peripheral Cholangiocarcinoma, Cholangiolar Carcinoma, Cholangiocellular Carcinoma) (ICC).
What interventions are being tested in trial NCT01938729?
The interventions under investigation include: Liver resection and placement of hepatic artery infusion pump (PROCEDURE), FLOXURIDINE (DRUG), DEXAMETHASONE (DRUG), GEMCITABINE (DRUG).
Who is sponsoring clinical trial NCT01938729?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01938729 being conducted?
This trial has 5 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01938729's enrollment target sits among peer trials
8 18th of 17 the lowest of 17 other Intrahepatic Cholangiocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Intrahepatic Cholangiocarcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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