Metastatic Colon CancerNCT04511793
Hepatic Artery Infusion (HAI) Program at Duke University
A study testing Medtronic Synchromed II pump in people with Metastatic Colon Cancer and Liver Cancer, run by Michael Lidsky, M.D..
Trial summary
The Duke HAI program was implemented in November 2018 and treated 30 patients in its first 17 months using the Medtronic Synchromed II device (only commercially available device suitable for HAI for cancer patients). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metastatic Colon Cancer, Liver Cancer, Intrahepatic Cholangiocarcinoma
- What is being tested?
- Medtronic Synchromed II pump
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 11 Dec 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age 18-80
- Eastern Cooperative Oncology Group score 0-1
- Fit for major surgery
- Without evidence of cirrhosis or portal hypertension
- Labs within 14 days of surgery: White blood cells ≥3 k/uL, Absolute Neutrophil Count ≥ 1.5 k/uL, Platelets ≥ 100K /uL, Creatinine ≤ 1.5 mg/dL, Total bilirubin ≤1.5 mg/dL
- Disease should be liver-only or liver-dominant
Show all 9Show fewer
- Arterial anatomy must be suitable, determined by the surgeon
- Primary tumor may be in place in the case of colorectal liver metastases. Patients may have colorectal liver metastases (unresectable, borderline resectable, resectable), or unresectable intrahepatic cholangiocarcinoma.
- Chemotherapy completed at least 3 weeks prior to surgery.
Who cannot join
- Patients younger than 18 or older than 80 years
- Eastern Cooperative Oncology Group score 2+
- Unfit for major surgery
- Inherent liver disease with evidence of cirrhosis or portal hypertension
- Widely metastatic disease is absolutely contraindicated
- Pregnant women (Women of childbearing potential who have not completed menopause, had a hysterectomy and/or both tubes and/or both ovaries removed and have a partner who is able to father children will have a blood or urine pregnancy test performed, and it must be negative in order to continue in the study.)
About this study
The Duke HAI program was implemented in November 2018 and treated 30 patients in its first 17 months using the Medtronic Synchromed II device (only commercially available device suitable for HAI for cancer patients). The Duke HAI program has demonstrated safety of HAI with an overall complication rate was 19%, similar to prior published data, with all but one complication (extrahepatic perfusion) salvaged. The Investigator has also demonstrated feasibility and efficacy of a new HAI program, with 95% of patients initiating therapy with promising hepatic response and disease control rates. This protocol will enable the team to continue this program. All eligible patients will receive the synchromed II pump with a Codman catheter and chemotherapy including FUDR, dexamethasone and heparin. Systemic chemotherapy will be given per standard of care.
Read the detailed description
This protocol is an interventional study for HAI therapy at Duke. The protocol is essentially for clinical treatment and the Investigator is not collecting safety and effectiveness data on the device itself. There are three primary indications for the hepatic artery infusion pump. The first are patients with unresectable, metastatic, liver-only or -dominant colorectal cancer. Although conversion to resection is a primary goal in these patients, most of these patients will die of liver disease and therefore controlling liver disease is a secondary goal to improve survival. The second group of patients are those with resectable, but high risk metastatic, liver-only or -dominant colorectal cancer. These patients are at high risk for liver recurrence, and HAI has demonstrated significant improvement in outcomes. The last group are patients with unresectable primary liver cancer, primarily intrahepatic cholangiocarcinoma. These patients have central tumors that are rarely resectable.
Eligible patients will have the following procedures performed during this study.
- On the day of surgery, the Synchromed II pump will be implanted and the Codman® catheter placed for chemotherapy infusion.
- During the hospital stay, patients will have:
- Daily physical examination to evaluate for the development of complications
- Daily blood tests to evaluate blood cell counts and liver function
- Initiation of a proton-pump inhibitor, if not already a home medication, which will continue indefinitely
- Assessment of side effects
Follow-Up Visits
Clinic visits and study activities will take place every 2 weeks after surgery, and include:
- Routine blood tests for blood cell counts, kidney function, and liver function
- Nuclear medicine SPECT/CT scan to confirm the pump and catheter are working properly. This is a type of scan where the images or pictures from two different types of scans are combined together.
- Start hepatic artery infusion (HAI) chemotherapy (at 2 week post-op).
HAI includes:
- Floxuridine (FUDR)
- Dexamethasone
- Heparin: (If heparin allergy, fondaparinux will be added)
- Normal saline
- Evaluation and treatment, including blood work and refilling the pump, every 2 weeks, until treatment is discontinued.
- Systemic chemotherapy (every 2 weeks after HAI started)
- Patients with metastatic colorectal cancer will receive systemic chemotherapy that will consist of either FOLFIRI, FOLFOX, or Irinotecan/oxaliplatin.
- Patients with cholangiocarcinoma will receive Gemcitabine/Oxaliplatin or Gemcitabine alone
When the chemotherapy regimen has completed, the Synchromed II pump will be reprogrammed every 4 weeks indefinitely.
- Being tested
- Medtronic Synchromed II pump
- Medical subject headings
- Colonic Neoplasms, Liver Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Synchromed II pumpDevice
The pump will be placed during surgery and the pump will be filled with a combination of floxuridine (FUDR), dexamethasone, heparin, and saline.
| Study group | Role | What they receive |
|---|---|---|
| Hepatic Artery Infusion (HAI) | Experimental | The Medtronic Synchromed II pump with the Codman® Catheter will be used to create the investigational device. The Medtronic Synchromed II pump is a surgically implantable device that allows for the delivery of high doses of chemotherapy directly to the liver, in order to treat cancer. The device is surgically implanted into a subcutaneous pocket in the abdominal wall, and the catheter is inserted into the arterial system of the liver, allowing for chemotherapeutic delivery. Receives: Device: Medtronic Synchromed II pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients Treated
Number of patients who completed HAI therapy
Measured: Surgery to 6 months post-surgery
Secondary outcomes (1)
Serious Adverse Events
SAEs experienced by patients receiving the synchromed II pump and HAI therapy
Measured: Surgery to one year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start11 Dec 2020
- Primary completion30 Jun 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: No subjects enrolled due to availability of device commercially.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colon CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Lidsky, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Lidsky, M.D., Duke University
- Investigators
- Michael Lidsky, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511793
- Sponsor's protocol ID
- Pro00106190
- Status last verified
- Jul 2021
- First submitted
- 11 Aug 2020
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Artery Infusion (HAI) Program at Duke University
- ClinicalTrials.gov ID
- NCT04511793
- Acronym / sponsor ID
- Pro00106190
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No subjects enrolled due to availability of device commercially.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Michael Lidsky, M.D.University, hospital or other
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 13 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Duke HAI program was implemented in November 2018 and treated 30 patients in its first 17 months using the Medtronic Synchromed II device (only commercially available device suitable for HAI for cancer patients). The Duke HAI program has demonstrated safety of HAI with an overall complication rate was 19%, similar to prior published data, with all but one complication (extrahepatic perfusion) salvaged. The Investigator has also demonstrated feasibility and efficacy of a new HAI program, with 95% of patients initiating therapy with promising hepatic response and disease control rates. This protocol will enable the team to continue this program. All eligible patients will receive the synchromed II pump with a Codman catheter and chemotherapy including FUDR, dexamethasone and heparin. Systemic chemotherapy will be given per standard of care.
Detailed description
This protocol is an interventional study for HAI therapy at Duke. The protocol is essentially for clinical treatment and the Investigator is not collecting safety and effectiveness data on the device itself. There are three primary indications for the hepatic artery infusion pump. The first are patients with unresectable, metastatic, liver-only or -dominant colorectal cancer. Although conversion to resection is a primary goal in these patients, most of these patients will die of liver disease and therefore controlling liver disease is a secondary goal to improve survival. The second group of patients are those with resectable, but high risk metastatic, liver-only or -dominant colorectal cancer. These patients are at high risk for liver recurrence, and HAI has demonstrated significant improvement in outcomes. The last group are patients with unresectable primary liver cancer, primarily intrahepatic cholangiocarcinoma. These patients have central tumors that are rarely resectable.
Eligible patients will have the following procedures performed during this study.
- On the day of surgery, the Synchromed II pump will be implanted and the Codman® catheter placed for chemotherapy infusion.
- During the hospital stay, patients will have:
- Daily physical examination to evaluate for the development of complications
- Daily blood tests to evaluate blood cell counts and liver function
- Initiation of a proton-pump inhibitor, if not already a home medication, which will continue indefinitely
- Assessment of side effects
Follow-Up Visits
Clinic visits and study activities will take place every 2 weeks after surgery, and include:
- Routine blood tests for blood cell counts, kidney function, and liver function
- Nuclear medicine SPECT/CT scan to confirm the pump and catheter are working properly. This is a type of scan where the images or pictures from two different types of scans are combined together.
- Start hepatic artery infusion (HAI) chemotherapy (at 2 week post-op).
HAI includes:
- Floxuridine (FUDR)
- Dexamethasone
- Heparin: (If heparin allergy, fondaparinux will be added)
- Normal saline
- Evaluation and treatment, including blood work and refilling the pump, every 2 weeks, until treatment is discontinued.
- Systemic chemotherapy (every 2 weeks after HAI started)
- Patients with metastatic colorectal cancer will receive systemic chemotherapy that will consist of either FOLFIRI, FOLFOX, or Irinotecan/oxaliplatin.
- Patients with cholangiocarcinoma will receive Gemcitabine/Oxaliplatin or Gemcitabine alone
When the chemotherapy regimen has completed, the Synchromed II pump will be reprogrammed every 4 weeks indefinitely.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatic Artery Infusion (HAI) | Experimental | Device: Medtronic Synchromed II pumpThe Medtronic Synchromed II pump with the Codman® Catheter will be used to create the investigational device. The Medtronic Synchromed II pump is a surgically implantable device that allows for the delivery of high doses of chemotherapy directly to the liver, in order to treat cancer. The device is surgically implanted into a subcutaneous pocket in the abdominal wall, and the catheter is inserted into the arterial system of the liver, allowing for chemotherapeutic delivery. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients age 18-80
- Eastern Cooperative Oncology Group score 0-1
- Fit for major surgery
- Without evidence of cirrhosis or portal hypertension
- Labs within 14 days of surgery: White blood cells ≥3 k/uL, Absolute Neutrophil Count ≥ 1.5 k/uL, Platelets ≥ 100K /uL, Creatinine ≤ 1.5 mg/dL, Total bilirubin ≤1.5 mg/dL
Key exclusion criteria (6 listed)
- Patients younger than 18 or older than 80 years
- Eastern Cooperative Oncology Group score 2+
- Unfit for major surgery
- Inherent liver disease with evidence of cirrhosis or portal hypertension
- Widely metastatic disease is absolutely contraindicated
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 |
|---|---|---|
| Medtronic Synchromed II pumpThe pump will be placed during surgery and the pump will be filled with a combination of floxuridine (FUDR), dexamethasone, heparin, and saline. | Device | Hepatic Artery Infusion (HAI) |
Primary outcome
Number of patients Treated
Time frame: Surgery to 6 months post-surgery
Number of patients who completed HAI therapy
1 secondary outcome
Serious Adverse Events
Time frame: Surgery to one year post-surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Individual participant dataSharing planned: No
Related trials for Metastatic Colon Cancer
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 1
Phase 1 Study Of SAR445877 In Combination With FOLFOX6 And Bevacizumab As First-Line Treatment For Microsatellite Stable Metastatic Colorectal Cancer
Phase 1, SAR445877
RecruitingPhase 1
A Study of [225Ac]Ac-AKY-2519 in Patients With B7-H3 Expressing Solid Tumors
NSCLC, NSCLC (Advanced Non-small Cell Lung Cancer)
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
Not yet recruitingObservational study
Real-World Treatment Patterns and Effectiveness of Anti-EGFR- and Anti-VEGF-based Therapies in Left-sided RAS Wild-Type Metastatic Colorectal Cancer
Metastatic Colorectal Cancer
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 Lidsky, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Synchromed II pump in people with Metastatic Colon Cancer and Liver Cancer, run by Michael Lidsky, M.D..
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 9 inclusion and 6 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: withdrawn, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of patients Treated (time frame: Surgery to 6 months post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jul 2021.