Bile Duct NeoplasmsNCT04276090
Codman Catheter/Synchromed Pump Hepatic Artery Chemotherapy for Unresectable Colorectal Metastases/Intrahepatic Cholangiocarcinoma
A study testing Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter., Hepatic artery infusion pump floxuridine and dexamethasone and Systemic chemotherapy for colorectal liver metastases in people with Bile Duct Neoplasms and Colorectal Neoplasms, run by Michael J Cavnar, MD at 1 site in United States.
Trial summary
Due to discontinuation of the Codman C3000 pump, an alternate device is necessary to continue serving patients in need of hepatic arterial infusion chemotherapy. This study aims to test the safety of hepatic artery infusion pump placement, a standard surgical procedure, and intraarterial chemotherapy initiation with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Neoplasms, Colorectal Neoplasms
- What is being tested?
- Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter., Hepatic artery infusion pump floxuridine and dexamethasone and Systemic chemotherapy for colorectal liver metastases
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2020to 14 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ≥ 18 years of age
- Histologically confirmed unresectable colorectal adenocarcinoma metastatic to the liver with no definitive clinical or radiographic evidence of extrahepatic disease. Clinical or radiographic evidence of metastatic disease to peri-hepatic lymph nodes will be allowed, provided it is amenable to resection.
- (OR)
- Histologically confirmed unresectable non-metastatic intrahepatic cholangiocarcinoma, with presence of less than 70% liver involvement. Clinical or radiographic evidence of metastatic disease to peri-hepatic lymph nodes will be allowed, provided it is amenable to resection.
- ECOG Performance Status of 0 - 1
- Lab Values ≤ 14 days prior to study enrollment:
Show all 12Show fewer
- absolute neutrophil count ≥1,500/mcL AST/ALT < 2.5 x institutional upper limit of normal (ULN) Platelets ≥ 100,000/mcL Creatinine < 1.5 mg/dL HGB > 9 g/dL Total Bilirubin ≤ 1.5 mg/dL
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- Prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to study enrollment.
- Any investigational agent is acceptable if last dose administered ≥ 3 months before study enrollment.
Who cannot join
- Presence of distant 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.
- Prior radiation to the liver, including external beam, SBRT, Y90. Prior radiation therapy to the pelvis is acceptable.
- Active infection, hepatic encephalopathy
- Clinical evidence of portal hypertension (ascites, gastroesophageal varices or portal vein thrombosis; surgically-related ascites does not exclude the patient)
- Female patients who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female patients of child-bearing potential must have negative pregnancy test ≤72 hours before surgery)
- If in the opinion of the treating investigator a patient has any serious medical problems which may preclude receiving this type of treatment
Show all 11Show fewer
- Patients with history or known presence of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke
- Serious or non-healing active wound, ulcer, or bone fracture
- Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the HAIP chemotherapy (i.e., investigational regimen)
- Patients with psychiatric illness or social situations that would limit compliance with study requirements. Examples include: active substance abuse, active severe EtOH abuse, etc.
- Inability to reliably commit to traveling to Lexington, KY every 2 weeks for duration of the study treatment (6 months). Patient must have readily identifiable, reliable primary and back-up modes of transportation regardless of weather.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Pilot of Hepatic Arterial Infusion Chemotherapy in a Rural Catchment Area, Using the Codman Vascular Catheter With the Synchromed II Pump, for Patients With Unresectable Colorectal Cancer Liver Metastases or Unresectable Intrahepatic Cholangiocarcinoma
Due to discontinuation of the Codman C3000 pump, an alternate device is necessary to continue serving patients in need of hepatic arterial infusion chemotherapy. This study aims to test the safety of hepatic artery infusion pump placement, a standard surgical procedure, and intraarterial chemotherapy initiation with the standard medication floxuridine (FUDR), using the Medtronic Synchromed II pump combined with the Codman arterial catheter in patients with unresectable (not removable by surgery) liver metastases from colorectal cancer and unresectable intrahepatic cholangiocarcinoma. This study will determine if complication and pump loss rates will be similar to previously published rates for the Codman system.
- Conditions
- Bile Duct Neoplasms, Colorectal Neoplasms
- Being tested
- Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter., Hepatic artery infusion pump floxuridine and dexamethasone, Systemic chemotherapy for colorectal liver metastases, Systemic chemotherapy for intrahepatic cholangiocarcinoma
- Keywords
- hepatic artery infusion pump, colorectal liver metastases, intrahepatic cholangiocarcinoma, FUDR, floxuridine
- Medical subject headings
- Bile Duct Neoplasms, Colorectal Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.Device
Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
Hepatic artery infusion pump floxuridine and dexamethasoneDrug
Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
Systemic chemotherapy for colorectal liver metastasesDrug
Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
Systemic chemotherapy for intrahepatic cholangiocarcinomaDrug
Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
| Study group | Role | What they receive |
|---|---|---|
| Colorectal liver metastases | Experimental | Patients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) Receives: Device: Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.; Drug: Hepatic artery infusion pump floxuridine and dexamethasone; Drug: Systemic chemotherapy for colorectal liver metastases |
| Intrahepatic cholangiocarcinoma | Experimental | Patients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone) Receives: Device: Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.; Drug: Hepatic artery infusion pump floxuridine and dexamethasone; Drug: Systemic chemotherapy for intrahepatic cholangiocarcinoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy
The percent of patients who complete the 1st cycle of hepatic artery chemotherapy will be tabulated. This is a conglomerate safety endpoint which is a surrogate for any complication that prevents delivery of hepatic artery chemotherapy via the device combination.
Measured: approximately 4 weeks
Secondary outcomes (11)
30-day Postoperative Serious Adverse Events Related to Pump Implantation
Tabulation of CTCAE serious adverse events attributed to pump implantation
Measured: 30 days
30-day Catheter Malfunction Due to Tubing Disconnect
Quantify the percent of patients with inability to meet primary outcome due to catheter disconnects.
Measured: 30 days
30-day Catheter Malfunction Due to Inability to Access Pump
Quantify the percent of patients with inability to meet primary outcome due to inability to access pump.
Measured: 30 days
Percent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function.
Percentage of patients who need secondary intervention (IR embolization, revision of pump or tubing) to achieve primary pump function.
Measured: Approximately 4 weeks
Percent of Screened Patients That Are Declined Due to High Risk of Failure as Determined by the Psychosocial Assessment Tool.
Patients are screen using a psychosocial assessment tool for high risk of hepatic artery pump loss/failure, percent declined will be tabulated.
Measured: Immediate, determined at screening visit
Percent Pump Loss Due to Inability to Attend Scheduled Followup Appointments.
Percent of patients that experience pump loss/failure due to inability to attend scheduled followup appointments will be tabulated.
Measured: Approximately 6 months
Number of Interventions (Phone Calls) to Assure Patients Attend Followup Appointments.
The number of staff contacts (phone calls) to assure patients keep their followup visits will be tabulated.
Measured: 6 months
Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 3 Months.
The percentage of patients who remain on pump chemotherapy at 3 months will be tabulated.
Measured: 3 months
Overall Response Rate at 6 Months
RECIST v1.1 will be used to assess overall response rate at 6 months.
Measured: 6 months
Percent of Patients Who Are Downstaged and Undergo Surgery
The percent of patients who are downstaged and undergo surgery will be tabulated.
Measured: 6 months
Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 6 Months.
The percentage of patients who remain on pump chemotherapy at 6months will be tabulated.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start1 May 2020
- Primary completion4 Jan 2022
- Study completion14 Jun 2022
Why it stopped: an alternate device became FDA approved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bile Duct NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with unresectable colorectal liver metastases (arm 1) and unresectable intrahepatic cholangiocarcinoma (arm 2), will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. All patients will receive hepatic artery infusion floxuridine, and then individual arms will receive disease-specific systemic chemotherapy.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael J Cavnar, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael J Cavnar, MD, University of Kentucky
- Investigators
- Michael J Cavnar, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276090
- Sponsor's protocol ID
- MCC-19-GI-109-PMC
- Status last verified
- Jul 2023
- First submitted
- 16 Feb 2020
- Last updated
- 25 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
McDonald HG, Cassim EB, Harper MM, Burke EE, Marcinkowski EF, Cavnar MJ, Pandalai PK, Kim J. The Development of Investigator-Initiated Clinical Trials in Surgical Oncology. Surg Oncol Clin N Am. 2023 Jan;32(1):13-25. doi: 10.1016/j.soc.2022.07.003. Epub 2022 Nov 3.
PubMed 36410913
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Pilot of Hepatic Arterial Infusion Chemotherapy in a Rural Catchment Area, Using the Codman Vascular Catheter With the Synchromed II Pump, for Patients With Unresectable Colorectal Cancer Liver Metastases or Unresectable Intrahepatic Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT04276090
- Acronym / sponsor ID
- MCC-19-GI-109-PMC
- Conditions
- Bile Duct Neoplasms, Colorectal Neoplasms
- Keywords
- hepatic artery infusion pump, colorectal liver metastases, intrahepatic cholangiocarcinoma, FUDR, floxuridine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: an alternate device became FDA approved
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Michael J Cavnar, MDUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 4 Jan 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 19 Feb 2020 (actual)
- Results
- Posted 17 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Due to discontinuation of the Codman C3000 pump, an alternate device is necessary to continue serving patients in need of hepatic arterial infusion chemotherapy. This study aims to test the safety of hepatic artery infusion pump placement, a standard surgical procedure, and intraarterial chemotherapy initiation with the standard medication floxuridine (FUDR), using the Medtronic Synchromed II pump combined with the Codman arterial catheter in patients with unresectable (not removable by surgery) liver metastases from colorectal cancer and unresectable intrahepatic cholangiocarcinoma. This study will determine if complication and pump loss rates will be similar to previously published rates for the Codman system.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with unresectable colorectal liver metastases (arm 1) and unresectable intrahepatic cholangiocarcinoma (arm 2), will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. All patients will receive hepatic artery infusion floxuridine, and then individual arms will receive disease-specific systemic chemotherapy.
| Arm | Type | Receives |
|---|---|---|
| Colorectal liver metastases | Experimental | Device: Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter., Drug: Hepatic artery infusion pump floxuridine and dexamethasone, Drug: Systemic chemotherapy for colorectal liver metastasesPatients with unresectable colorectal liver metastases will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (FOLFOX, FOLRIRI, or oxaliplatin/irinotecan, or panitumumab if KRAS/NRAS wild type) |
| Intrahepatic cholangiocarcinoma | Experimental | Device: Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter., Drug: Hepatic artery infusion pump floxuridine and dexamethasone, Drug: Systemic chemotherapy for intrahepatic cholangiocarcinomaPatients with unresectable intrahepatic cholangiocarcinoma will undergo hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. Patients will then receive hepatic artery infusion floxuridine as well as disease-appropriate systemic chemotherapy (gemcitabine/oxaliplatin or gemcitabine alone) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients ≥ 18 years of age
- Histologically confirmed unresectable colorectal adenocarcinoma metastatic to the liver with no definitive clinical or radiographic evidence of extrahepatic disease. Clinical or radiographic evidence of metastatic disease to peri-hepatic lymph nodes will be allowed, provided it is amenable to resection.
- (OR)
- Histologically confirmed unresectable non-metastatic intrahepatic cholangiocarcinoma, with presence of less than 70% liver involvement. Clinical or radiographic evidence of metastatic disease to peri-hepatic lymph nodes will be allowed, provided it is amenable to resection.
- ECOG Performance Status of 0 - 1
Key exclusion criteria (11 listed)
- Presence of distant 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.
- Prior radiation to the liver, including external beam, SBRT, Y90. Prior radiation therapy to the pelvis is acceptable.
- Active infection, hepatic encephalopathy
- Clinical evidence of portal hypertension (ascites, gastroesophageal varices or portal vein thrombosis; surgically-related ascites does not exclude the patient)
- Female patients who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female patients of child-bearing potential must have negative pregnancy test ≤72 hours before surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter. | Device | Colorectal liver metastases, Intrahepatic cholangiocarcinoma |
| Hepatic artery infusion pump floxuridine and dexamethasonePatients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump | Drug | Colorectal liver metastases, Intrahepatic cholangiocarcinoma |
| Systemic chemotherapy for colorectal liver metastasesPatients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type) | Drug | Colorectal liver metastases |
| Systemic chemotherapy for intrahepatic cholangiocarcinomaPatients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone) | Drug | Intrahepatic cholangiocarcinoma |
Primary outcome
Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy
Time frame: approximately 4 weeks
The percent of patients who complete the 1st cycle of hepatic artery chemotherapy will be tabulated. This is a conglomerate safety endpoint which is a surrogate for any complication that prevents delivery of hepatic artery chemotherapy via the device combination.
11 secondary outcomes
30-day Postoperative Serious Adverse Events Related to Pump Implantation
Time frame: 30 days
30-day Catheter Malfunction Due to Tubing Disconnect
Time frame: 30 days
30-day Catheter Malfunction Due to Inability to Access Pump
Time frame: 30 days
Percent of Patients That Require Secondary Intervention in Order to Obtain Primary Pump Function.
Time frame: Approximately 4 weeks
Percent of Screened Patients That Are Declined Due to High Risk of Failure as Determined by the Psychosocial Assessment Tool.
Time frame: Immediate, determined at screening visit
Percent Pump Loss Due to Inability to Attend Scheduled Followup Appointments.
Time frame: Approximately 6 months
Number of Interventions (Phone Calls) to Assure Patients Attend Followup Appointments.
Time frame: 6 months
Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 3 Months.
Time frame: 3 months
Overall Response Rate at 6 Months
Time frame: 6 months
Percent of Patients Who Are Downstaged and Undergo Surgery
Time frame: 6 months
Percent of Patients Who Remain on Hepatic Artery Infusion Pump Chemotherapy at 6 Months.
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36410913McDonald HG, Cassim EB, Harper MM, Burke EE, Marcinkowski EF, Cavnar MJ, Pandalai PK, Kim J. The Development of Investigator-Initiated Clinical Trials in Surgical Oncology. Surg Oncol Clin N Am. 2023 Jan;32(1):13-25. doi: 10.1016/j.soc.2022.07.003. Epub 2022 Nov 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael J Cavnar, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter., Hepatic artery infusion pump floxuridine and dexamethasone and Systemic chemotherapy for colorectal liver metastases in people with Bile Duct Neoplasms and Colorectal Neoplasms, run by Michael J Cavnar, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Completion of 1st Cycle of Hepatic Artery Chemotherapy (time frame: approximately 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04276090, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.