← Back to Search

Anti-metabolites

Chemotherapy +/− FUDR/Dexamethasone Pump for Bile Duct Cancer

Phase 2
Recruiting
Led By Andrea Cercek, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Radiographically measurable disease. Measurable disease is defined as disease that can be assessed with 2-dimensional measurements on a cross-sectional imaging. Minimum lesion size is 2 cm in greatest diameter as per RECIST criteria.
Disease must be considered unresectable at the time of preoperative evaluation.*
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will compare a new combination therapy to standard chemotherapy in people with inoperable cholangiocarcinoma. The goal is to see if the new therapy extends life by at least 3 months on average.

Who is the study for?
This trial is for adults with a specific type of liver cancer called intrahepatic cholangiocarcinoma that can't be removed by surgery. Participants should have measurable disease, no prior treatments with FUDR or radiation to the liver, and must not have other cancers within the last 3 years. They need to be in good physical condition (ECOG 0-1) and able to undergo general anesthesia.Check my eligibility
What is being tested?
The study compares standard chemotherapy (Gemcitabine and Oxaliplatin) alone versus combined with an implanted pump delivering Floxuridine and Dexamethasone directly into the liver. The goal is to see if adding the pump improves time without disease progression by at least three months compared to chemotherapy alone.See study design
What are the potential side effects?
Potential side effects include reactions from Gemcitabine and Oxaliplatin such as nausea, fatigue, low blood counts leading to infection risk; from Dexamethasone like increased appetite, sleep problems; and complications related to the implanted device like infection or device malfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer can be measured on scans and is at least 2 cm big.
Select...
My condition cannot be treated with surgery.
Select...
I am 18 years old or older.
Select...
My cancer is a specific type called intrahepatic cholangiocarcinoma, confirmed by a test.
Select...
I have chronic hepatitis or cirrhosis but my liver is still functioning well.
Select...
My hemoglobin level is above 7 g/dL and a radiologist will check my liver.
Select...
My cancer has spread only to my liver, and possibly nearby lymph nodes that can be removed.
Select...
I am fully active or can carry out light work.
Select...
I am fit for surgery that involves exploring the abdomen and placing a pump in the liver artery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
assess progression-free survival (PFS)
Secondary outcome measures
Overall survival (OS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: HAI FUDR plus GemOx (Arm 1)Experimental Treatment5 Interventions
Surgical HAI pump placement. 2. HAI FUDR [(0.12 mg/kg/day) x wt (kg) x (30ml) / pump flow rate ] and dexamethasone [1 mg/day * 30] / pump flow rate ] on Day 1 of each cycle. Chemotherapy with HAI FUDR/Dex will commence no sooner than 14 days postsurgical placement of HAI pump. 3. Gemcitabine (800 mg/m2 IV over 30 minutes) and oxaliplatin (85 mg/ m2 IV over 120 minutes on Days 1 and 15 of each cycle; however, for patients in Arm 1, initiation of systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first dose of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.
Group II: GemOx alone (Arm 2)Active Control2 Interventions
Gemcitabine (800 mg/m2 IV over 30 minutes) and oxaliplatin (85 mg/m2 IV over approximately 120 minutes) on Days 1 and 15 of each 28-day cycle.For patients in Arm 2, systemic therapy will be administered on Days 1 and Day 15 of each Cycle on a 28-day cycle basis, compromised of Gemcitabine and Oxaliplatin. If a patient randomized to Arm 2 has intrahepatic progression on any follow-up scan during study treatment, that patient will be eligible to crossover to Arm 1 and commence to pump placement surgery and HAI FUDR treatment. Patients with any extrahepatic progression will not be eligible to utilize the crossover arm. Arm 2 patients will have 28 days from date of the scan showing intrahepatic progression to proceed to the crossover arm.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Oxaliplatin
2011
Completed Phase 4
~2560
Dexamethasone
2007
Completed Phase 4
~2590
Implanted Medical Device
2019
Completed Early Phase 1
~80

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,929 Previous Clinical Trials
597,054 Total Patients Enrolled
2 Trials studying Intrahepatic Cholangiocarcinoma
63 Patients Enrolled for Intrahepatic Cholangiocarcinoma
Andrea Cercek, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
9 Previous Clinical Trials
1,922 Total Patients Enrolled
1 Trials studying Intrahepatic Cholangiocarcinoma
8 Patients Enrolled for Intrahepatic Cholangiocarcinoma

Media Library

Gemcitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT04891289 — Phase 2
Intrahepatic Cholangiocarcinoma Research Study Groups: GemOx alone (Arm 2), HAI FUDR plus GemOx (Arm 1)
Intrahepatic Cholangiocarcinoma Clinical Trial 2023: Gemcitabine Highlights & Side Effects. Trial Name: NCT04891289 — Phase 2
Gemcitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04891289 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the extent of Gemcitabine's patient risks?

"There is some data supporting Gemcitabine's safety, but since this is only a Phase 2 trial, there is no information yet on whether or not it is effective. Therefore, it received a score of 2."

Answered by AI

Is this research project actively looking for new participants?

"That is correct. The listings on clinicaltrials.gov show that this study is still open and recruiting patients. This trial was first posted on May 7th, 2021, with the most recent update being September 27th, 2022. They are looking for 164 individuals to participate at 9 different sites."

Answered by AI

How many people are the investigators enrolling in this research project?

"In order to obtain the desired data, 164 individuals that fit the bill are required to partake in this experiment. These participants must visit one of the many specified locations which include Memorial Sloan Kettering Cancer Center in New york and North carolina, or Memorial Sloan Kettering Commack in New jersey."

Answered by AI

What is Gemcitabine commonly prescribed for?

"Gemcitabine is commonly used to treat ophthalmia, sympathetic. It can also be used effectively against branch retinal vein occlusion, small cell lung cancer (sclc), and macular edema."

Answered by AI

How many hospitals are participating in this experiment?

"Memorial Sloan Kettering Cancer Center is the primary location for this study, however it is also taking place in New jersey, North carolina, Missouri and 9 other states."

Answered by AI
~45 spots leftby May 2025