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NCT01862315 · ClinicalTrials.gov registry record · Phase 2
Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)
A Phase 2 study of Intrahepatic Cholangiocarcinoma and Peripheral Cholangiocarcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
- 6
- Study locations
NCT01862315: Completed Phase 2 study of Intrahepatic Cholangiocarcinoma and Peripheral Cholangiocarcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT01862315 is a Phase 2 study of Intrahepatic Cholangiocarcinoma and Peripheral Cholangiocarcinoma that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 55 participants, below the 132-participant average among 17 other Intrahepatic Cholangiocarcinoma trials with a reported enrollment target (58% lower). The trial reports 6 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01862315, a Phase 2 study of Intrahepatic Cholangiocarcinoma and Peripheral Cholangiocarcinoma, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to use both, liver pump treatment and systemic chemotherapy, to assess the effects this type of treatment has on the patient and the tumor. Liver pump treatment uses a metal pump that is surgically placed in the abdomen and gives chemotherapy directly to the liver. Systemic chemotherapy gives chemotherapy through a vein \[intravenously (IV)\] and treats the whole body. This type of treatment has been done before and had shown that people with both pump and systemic chemotherapy had improved results. The investigators hope that this combination of treatments improves the response to chemotherapy and reduces the spread of the disease. Another purpose of this study is to learn the clinical importance of a specific type of MRI scan. The investigators would like to see if this type of MRI will help predict the response to the treatment and see if they could help the physician with their treatment plan. These scans will be done at specific time points. The last purpose of this study is to learn more about how the tumor interacts with the chemotherapy. This will be done through a biopsy taken during surgery and blood draws at specific time points. Permission from patients entering the study will be obtained to take normal and tumor liver biopsies at the time of surgery. These samples are voluntary and optional.
Primary Outcome
Treatment evaluation will be done using RECIST (version 1.1). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Conditions Studied
Interventions
- DRUG Oxaliplatin
- DRUG Gemcitabine
- OTHER MRI
- DRUG dexamethasone
- DRUG Floxuridine (FUDR)
Study Locations (6)
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau - Uniondale
New Jersey
- Memorial Sloan Kettering Cancer Center - Basking Ridge
- Memorial Sloan Kettering Monmouth - Middletown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2013-05 |
| Est. Completion | 2025-03-18 |
| Phase | Phase 2 |
What the finished NCT01862315 record still lists
NCT01862315 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 132-participant average among 17 other Intrahepatic Cholangiocarcinoma trials with a reported enrollment target (58% lower).
The record links to 4 conditions, with Intrahepatic Cholangiocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Oxaliplatin is the first listed.
NCT01862315 lists 6 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT01862315 about?
NCT01862315 is a clinical study titled "Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)". The purpose of this study is to use both, liver pump treatment and systemic chemotherapy, to assess the effects this type of treatment has on the patient and the tumor. Liver pump treatment uses a metal pump that is surgically placed in the abdomen and gives chemotherapy directly to the liver. Syste...
What is the current status of trial NCT01862315?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2013-05. Estimated completion is 2025-03-18.
What conditions does trial NCT01862315 study?
This clinical trial studies the following conditions: Intrahepatic Cholangiocarcinoma, Peripheral Cholangiocarcinoma, Cholangiolar Carcinoma, Cholangiocellular Carcinoma.
What interventions are being tested in trial NCT01862315?
The interventions under investigation include: Oxaliplatin (DRUG), Gemcitabine (DRUG), MRI (OTHER), dexamethasone (DRUG), Floxuridine (FUDR) (DRUG).
Who is sponsoring clinical trial NCT01862315?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01862315 being conducted?
This trial has 6 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 NCT01862315's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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