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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 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
~9520
Gemcitabine
2017
Completed Phase 3
~2070
Oxaliplatin
2011
Completed Phase 4
~2560

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,939 Previous Clinical Trials
588,801 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
~4 spots leftby May 2025
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