HAI Chemotherapy for Bile Duct Cancer

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: FUDR

Disqualifiers: Distant metastasis, Sclerosing cholangitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 6 months

55 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

William Jarnagin, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Patients must be able to read, understand, and sign informed consent

Radiographically measurable disease with minimum lesion size of 2cm in greatest diameter as per RECIST criteria

Platelet count ≥ 75,000/mm3

Exclusion Criteria

Pregnant or lactating women

Life expectancy less than 12 weeks

Inability to comply with study and/or follow-up procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Placement

Surgical placement of the hepatic arterial infusion pump

2 weeks

1 visit (in-person)

Treatment

Participants receive HAI FUDR/Dex and systemic chemotherapy with Gemcitabine and Oxaliplatin

6 months

Bi-weekly visits for chemotherapy administration

Imaging and Monitoring

MRI and CT scans to monitor treatment response and tumor interaction

9 months

MRI at baseline, 3, 6, and 9 months; CT scans as part of routine care

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Dexamethasone
• Floxuridine (FUDR)
• Gemcitabine
• Hepatic Arterial Infusion (HAI)
• Oxaliplatin

Trial Overview 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.

Participant Groups

Group I: pts who have had prior oxaliplatin & have existing neuropathy Experimental Treatment 4 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 therapy Experimental Treatment 6 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 chemo Experimental Treatment 6 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+