← Back to Search

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

Must not have

Prior treatment with FUDR

Prior external beam radiation therapy to the liver

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

My condition cannot be treated with surgery.

Select...

I have had chemotherapy before.

Select...

I am 21 years old or older.

Select...

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

Select...

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

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been treated with FUDR before.

Select...

I have had radiation therapy targeted at my liver before.

Select...

I have been diagnosed with sclerosing cholangitis.

Select...

My cancer has spread, but it can be surgically removed.

Select...

I currently have an infection.

Select...

I have not had cancer, other than non-melanoma skin cancer, in the last 3 years.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

progression free survival for Cohort 1

progression free survival for Cohort 2

response for Cohort 3

Secondary study objectives

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

Therapeutic procedure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Floxuridine (FUDR)

2018

Completed Phase 2

~40

dexamethasone

1995

Completed Phase 3

~9520