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Alkylating agents

HAI Chemotherapy for Bile Duct Cancer

Phase 2

Waitlist Available

Led By William Jarnagin, 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

Disease considered unresectable at the time of preoperative evaluation

Patient previously treated with systemic chemotherapy eligible

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing a new treatment for liver cancer that involves a pump and systemic chemotherapy. MRI scans will be done to see if they can help predict the response to the treatment.

Who is the study for?

This trial is for adults over 21 with a specific liver cancer (intrahepatic cholangiocarcinoma) that can't be removed by surgery. They should have less than 70% liver involvement, good physical function, and acceptable blood counts. People with chronic hepatitis or cirrhosis can join if it's mild. Prior chemotherapy and certain local treatments are okay, but no prior FUDR treatment or radiation to the liver.Check my eligibility

What is being tested?

The study tests combining liver pump treatment delivering chemotherapy directly to the liver with systemic chemotherapy treating the whole body via IV. It aims to improve response rates and control disease spread. The trial also evaluates a special MRI scan's ability to predict treatment response and guide physicians.See study design

What are the potential side effects?

Potential side effects include those typical of chemotherapy such as nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, possible damage to organs like kidneys or nerves causing numbness or tingling in hands/feet.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition cannot be treated with surgery.

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I have had chemotherapy before.

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I am 21 years old or older.

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I am fit for surgery and anesthesia with a KPS score of 60% or higher.

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My bile duct cancer diagnosis has been confirmed by a specialist.

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Less than 70% of my liver is affected by cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

progression free survival for Cohort 1

progression free survival for Cohort 2

response for Cohort 3

Secondary outcome measures

Correlative objective of of dynamic contrast enhanced (DCE)-MRI imaging of intrahepatic cholangiocarcinoma before treatment and early during the course of treatment.

Therapeutic procedure

Trial Design

3Treatment groups

Experimental Treatment

Group I: pts who have had prior oxaliplatin & have existing neuropathyExperimental Treatment4 Interventions

All patients receive will receive gemcitabine alone with HAI FUDR/Dex Gemcitabine (800 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter.

Group II: patients who have failed systemic therapyExperimental Treatment6 Interventions

All patients receive HAI FUDR ([0.12 mg/kg/day kg 30] / pump flow rate)& dexamethasone ({1 mg/m2/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. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) & Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 & 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, & then every 2 weeks thereafter. Clinical MRI examinations of the abdomen & pelvis are obtained at baseline following surgery, prior to treatment initiation & 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 & 9 thereafter A non-contrast CT of chest, abdomen & pelvis will also be obtained as part of routine clinical care.

Group III: No prior chemo or responded/stable with prior chemoExperimental Treatment6 Interventions

All patients receive HAI FUDR ([0.12 mg/kg/day kg 30] / pump flow rate)& dexamethasone ({1 mg/m2/day30} 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. All patients receive Gemcitabine (800 mg/m2 IV over 30 minutes) & Oxaliplatin (85 mg/m2 IV over 120 minutes) on Days 1 & 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, & then every 2 weeks thereafter. Clinical MRI examinations of the abdomen & pelvis are obtained at baseline following surgery, prior to treatment initiation & 4 weeks after initiation of HAI FUDR. Subsequently, the patient will undergo MRI approximately at months 3, 6 & 9 thereafter A non-contrast CT of chest, abdomen & pelvis will also be obtained as part of routine clinical care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

dexamethasone

1995

Completed Phase 3

~9860

Gemcitabine

2017

Completed Phase 3

~2070

Oxaliplatin

2011

Completed Phase 4

~2560

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,755 Total Patients Enrolled

2 Trials studying Intrahepatic Cholangiocarcinoma

172 Patients Enrolled for Intrahepatic Cholangiocarcinoma

William Jarnagin, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

4 Previous Clinical Trials

369 Total Patients Enrolled

Media Library

Floxuridine (FUDR) (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01862315 — Phase 2

Intrahepatic Cholangiocarcinoma Research Study Groups: No prior chemo or responded/stable with prior chemo, patients who have failed systemic therapy, pts who have had prior oxaliplatin & have existing neuropathy

Intrahepatic Cholangiocarcinoma Clinical Trial 2023: Floxuridine (FUDR) Highlights & Side Effects. Trial Name: NCT01862315 — Phase 2

Floxuridine (FUDR) (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01862315 — Phase 2

Frequently Asked Questions

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

How many different hospitals are participating in this research project?

"Currently, there are 6 sites where this trial is recruiting patients. They are situated in Uniondale, Commack and Harrison as well as other locations. To cut down on travel time and effort, please select the site nearest to you when enrolling."

Answered by AI

Are there any current openings for participants in this clinical trial?

"Unfortunately, this particular clinical trial is not looking for new candidates at the moment. It was first posted on May 1st, 2013 and last updated June 1st, 2022. Although 4044 other trials are currently enrolling patients."

Answered by AI

Is it legal to use MRI machines in the United States?

"While Phase 2 trials are not as well-supported by data as Phase 3, our team believes that MRI is safe enough to receive a score of 2."

Answered by AI

What does an MRI show doctors about a patient?

"ophthalmia, sympathetic is most frequently treated with MRI. However, this medical imaging technique can also be used to treat other disorders such as branch retinal vein occlusion, small cell lung cancer (sclc), and macular edema."

Answered by AI

What is the ceiling for patient enrollment in this research project?

"This study is not recruiting patients at the moment. It was initially posted on May 1st, 2013 and updated June 1st, 2022. If you are searching for other studies, there 2720 trials actively looking for patients with cholangiocarcinoma and 1324 MRI trials that are currently recruiting participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)

2013. "Hepatic Arterial Infusion (HAI) With Floxuridine (FUDR) and Dexamethasone (Dex) Combined With Systemic Gemcitabine and Oxaliplatin in Patients With Unresectable Intrahepatic Cholangiocarcinoma (ICC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01862315.

All > Intrahepatic Cholangiocarcinoma > Bile Duct Cancer