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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.*

Must not have

Patients previously treated with systemic chemotherapy for IHC will be non-eligible.

Prior treatment with FUDR.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

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My cancer can be measured on scans and is at least 2 cm big.

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My condition cannot be treated with surgery.

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I am 18 years old or older.

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My cancer is a specific type called intrahepatic cholangiocarcinoma, confirmed by a test.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I have not had chemotherapy for my cancer.

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I have been treated with FUDR before.

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I have had radiation therapy targeted at my liver before.

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I have been diagnosed with sclerosing cholangitis.

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I have had treatment to destroy liver tumors.

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I have signs of high blood pressure in the liver veins.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

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

Primary study objectives

assess progression-free survival (PFS)

Awards & Highlights

No Placebo-Only Group

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

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

~1920

Oxaliplatin

2011

Completed Phase 4

~2890