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Study of Safety/Feasibility of a Hybrid Model of Tertiary and Community Delivery of Hepatic Artery Infusion Chemotherapy

ConditionsColorectal Cancer MetastaticIntrahepatic Cholangiocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMichael J Cavnar, MD

About this trial

The goal of this clinical trial is to help learn about the safety and feasibility of hepatic artery infusion chemotherapy for those who have colorectal liver metastases, both resectable and unresectable, or unresectable intrahepatic cholangiocarcinoma. The main questions it aims to answer are:

* safety and feasibility of installing a pump that deliveries chemotherapy to the hepatic artery (the blood vessel that supplies blood to the liver) * help learn more about the safety of patients having pump refills at home or a local clinic versus having it routinely done at the hospital

Participants will have surgery to install a pump which is a standard surgical procedure. After surgery, participants will select to either receive treatment at the hospital facility or with a community oncologist that will provide cancer care to participants close to home, rather than in a large hospital or academic medical center.

The main treatment on study will last about 3-4 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Colorectal adenocarcinoma metastatic to the liver which is either Unresectable (group A) or Resectable (group B; ie, will be completely resected), AND with no definitive clinical or radiographic evidence of extrahepatic disease other than: metastatic disease to resectable peri-hepatic lymph nodes; up to 5 proven or suspected lung metastases, provided they are stable or responding in number and size for a minimum of 2-months of systemic chemotherapy and are amenable to SBRT or resection. or

Histologically confirmed unresectable intrahepatic cholangiocarcinoma (group C), with presence of less than 70% liver involvement with no definitive clinical or radiographic evidence of extrahepatic metastatic disease other than resectable perihepatic lymph nodes.

Patients > or equal 18 years of age

ECOG Performance Status of 0 - 1 (APPENDIX C)

Disqualifiers

Presence of distant non-liver metastatic disease confirmed by radiographic evaluation. Clinical or radiographic evidence of metastatic disease to regional peri-hepatic lymph nodes will be allowed, provided it is amenable to resection. For the colorectal carcinoma only: Up to 5 lung metastases are allowable, provided they are stable (or responding) in number and size for minimum of 2-mos of systemic chemo and are amenable to SBRT.

Microsatellite instability (MSI) or Mismatch repair deficiency (MMR-D)

Prior radiation to the liver, including external beam, SBRT, Y90. Prior radiation therapy to the pelvis is acceptable

Bevacizumab (Avastin®) cannot be given concurrently with HAI FUDR. Patients can previously have received it with a minimum 6-week washout period

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hepatic Artery Infusion Pump (HAIP)

    Device

    HAIP will be filled with mixture of FUDR + Dexamethasone, Heparin \& Saline for a 14 day infusion of drugs, followed by a 14 day infusion of Heparin+Saline.

  • Standard Treatment

    Procedure/Surgery

    systemic therapy per standard-of-care and institutional standards; visits every two weeks and standard manual HAI dose calculation

  • Community Treatment

    Procedure/Surgery

    systemic therapy fill by home infusion based on TO orders. In person visit with CO for systemic chemotherapy with dose recommendations from TO. Locally obtained testing with telehealth visits with TO team.

  • Systemic Chemotherapy Standard of Care

    Drug

    Dosing of systemic therapy will be according to established routine practice guidelines. Patients with colon cancer will receive systemic chemotherapy that will consist of either FOLFIRI, FOLFOX, or Irinotecan/oxaliplatin at the discretion of the oncologist. Patients with intrahepatic cholangiocarcinoma will receive Gemcitabine/Oxaliplatin or Gemcitabine alone, at the discretion of the oncologist.

  • Standard Of Care targeting driver mutations

    Drug

    Per current SOC guidelines, EGFR inhibitors targeting driver mutations (e.g., RAS wild-type) will be administered as appropriate (FDA-approved agents such as Panitumumab for EGFR)

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Tertiary Oncology Cohort (TO)Active comparator 4 interventions
Group B: Community Oncology Cohort (CO)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Percent of participants with HAI Pump still in use at 3 months

The primary outcome is safety, defined as: continued functional / in-use HAI pump (either for FUDR fills or maintenance saline/glycerine fills) at 3-months.

Time frame
3 months

Secondary outcomes

1

Number of Adverse events according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time frame
4 months
2

Number of participants transferring care

Determine the number of Community Oncology (CO) HAI patients that permanently transfer their care to tertiary center due to CO access issues or other reasons

Time frame
3 months
3

Number of administered HAI cycles

Tabulate the number of administered HAI cycles at 1-year post-enrollment

Time frame
1 year
4

Number of failed access visits by home infusion

Home infusion HAI access issues for Cycles 1 - 3, assessed by the number of failed access visits by home infusion requiring a trip to the institution for pump access/troubleshooting

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Michael J Cavnar, MD

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov
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