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Anti-metabolites

Floxuridine for Bile Duct Cancer

Phase 1
Waitlist Available
Led By William Chapman, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of 2 cycles of treatment by all patients (approximately 4 years)
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of delivering high concentrations of a chemo drug directly to liver tumors. This may improve outcomes for patients with locally advanced cholangiocarcinoma.

Eligible Conditions
  • Bile Duct Cancer
  • Liver Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of 2 cycles of treatment by all patients (approximately 4 years)
This trial's timeline: 3 weeks for screening, Varies for treatment, and completion of 2 cycles of treatment by all patients (approximately 4 years) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose-limiting toxicities (DLTs)
Secondary outcome measures
Imaging biomarkers of tumor response
Number and grade of adverse events
Overall survival
+2 more

Side effects data

From 2010 Phase 2 trial • 29 Patients • NCT00448760
31%
Grade 3 Fatigue
28%
Grade 3 Neutropenia
17%
Grade 3 Diarrhea
10%
Grade 3 Febrile Neutropenia
10%
Grade 4 Neutropenia
3%
Grade 3Thrombocytopenia
3%
Grade 3 Deep Venous Thrombosis
3%
Grade 3 Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C (HAI FUDR + gemcitabine + oxaliplatin)Experimental Treatment4 Interventions
Consists of Cohort C1, C2, C3, and C4. Enrollment to specific cohorts will depend on the number of DLTs in each cohort. Each cohort has a different dose of FUDR, gemcitabine, and oxaliplatin. Gemcitabine IV will be given on Days 1 and 15 of each 28 day cycle. Oxaliplatin IV will be given on Days 1 and 15 of each 28 days cycle. 14-42 days after surgery for insertion of the HAI pump, floxuridine (FUDR) and dexamethasone plus heparin in normal saline to a total volume of 30 ml will be administered through the HAI pump. This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump. The pump will be emptied and refilled with heparinized normal saline and dexamethasone on Day 15 of each cycle to be infused over the next 14 days.
Group II: Arm B (HAI FUDR + gemcitabine)Experimental Treatment3 Interventions
Consists of Cohort B1, B2, and B3. Enrollment to specific cohorts will depend on the number of DLTs in each cohort. Each cohort has a different dose of FUDR and gemcitabine. Gemcitabine IV will be given on Days 1, 8, and 15 of each 28 day cycle in Cohort B1 Gemcitabine IV will be given on Days 1 and 15 of each 28 day cycle in Cohort B2 & B3 14-42 days after surgery for insertion of the HAI pump, floxuridine (FUDR) and dexamethasone plus heparin in normal saline to a total volume of 30 ml will be administered through the HAI pump. This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump. The pump will be emptied and refilled with heparinized normal saline and dexamethasone on Day 15 of each cycle to be infused over the next 14 days.
Group III: Arm A (HAI FUDR alone)Experimental Treatment2 Interventions
14-42 days after surgery for insertion of the HAI pump, floxuridine (FUDR) and dexamethasone plus heparin in normal saline to a total volume of 30 ml will be administered through the HAI pump. This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump. The pump will be emptied and refilled with heparinized normal saline and dexamethasone on Day 15 of each cycle to be infused over the next 14 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
Floxuridine
2012
Completed Phase 2
~180
Dexamethasone
2007
Completed Phase 4
~2590
Oxaliplatin
2011
Completed Phase 4
~2560

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,780 Total Patients Enrolled
William Chapman, M.D.Principal InvestigatorWashington University School of Medicine

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Hepatic Arterial Infusion in Treating Patients With Locally Advanced, Non-Metastatic Cholangiocarcinoma
2012. "Hepatic Arterial Infusion in Treating Patients With Locally Advanced, Non-Metastatic Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01525069.
~2 spots leftby Apr 2025
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