Colorectal CancerPhase 2NCT03693807
A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma
A Phase 2 study testing Medtronic pump and Codman catheter, Floxuridine (FUDR) and Gemcitabine in people with Colorectal Cancer and Cholangiocarcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
This study is being done to answer the following question: Is the combination of the Medtronic pump and the Codman catheter device a safe alternative to the C3000 Codman pump for delivering chemotherapy directly into the liver of patients with metastatic colorectal cancer or cholangiocarcinoma? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Cholangiocarcinoma
- What is being tested?
- Medtronic pump and Codman catheter, Floxuridine (FUDR) and Gemcitabine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 7 sitesUnited States
- Study dates
- 18 Oct 2018to 27 Jun 2024
- Phase
- Phase 2
- 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
- History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinicalyl or radiographically confirmed extrahepatic disease (or) Histologically confirmed cholangiocarcinoma (Clinical or radiographic evidence of metastatic disease that has been resected is allowed, provided there is no recurrence in that area prior to protocol consent)
- Confirmation of diagnosis must be performed at MSKCC
- Patient may have completely resected hepatic metastases without current evidence of other metastatic disease
- Lab values ≤14 days prior to registration:
- WBC ≥2.5 K/uL
- Platelets ≥100,000/uL
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- Creatinine <1.7mg/dL
- HGB ≥ 8.5 gm/dL
- Total Bilirubin ≤1.5 mg/dl
- Prior chemotherapy is acceptable if last dose given ≥3 weeks prior to registration to this study. [Note: no chemotherapy to be given after resection of liver lesions prior to treatment on this study]
- Any investigation agent is acceptable if administered ≥3 months before planned first dose on this protocol
- KPS ≥60%
- Patients ≥18 years of age
Who cannot join
- Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if competed at least 4 weeks prior to the planned first dose of treatment on protocol)
- Active infection, ascites, hepatic encephalopathy
- 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 treatment start)
- If in the opinion of the treating investigator a patient has any serious medical problems which may preclude receiving this type of treatment
- Patients with current evidence of hepatitis A, B, C (i.e., active hepatitis)
- Patients with history or known presence of primary CNS tumors, seizures not well-controlled with standard medical therapy, or history of stroke will also be excluded
Show all 12Show fewer
- Serious or non-healing active wound, ulcer, or bone fracture
- History of other malignancy, except:
- Malignancy treated with curative intent and with no known active disease present for ≥3 years prior to registration and felt to be at low risk for recurrence by the treating physician
- Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease
- Adequately treated cervical carcinoma in situ without evidence of disease
- There is no exclusion of patients based on sex, ethnicity or race. For these reasons, the study results are expected to be generalizable to the Medicare beneficiary population.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553
About this study
Official title: A Pilot Protocol Evaluating Safety of Using the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With Colorectal Carcinoma or Cholangiocarcinoma
This study is being done to answer the following question:
Is the combination of the Medtronic pump and the Codman catheter device a safe alternative to the C3000 Codman pump for delivering chemotherapy directly into the liver of patients with metastatic colorectal cancer or cholangiocarcinoma?
Read the detailed description
Group 1 unresectable liver metastases from colorectal cancer
- Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin (anti- EGFR agent may be added to any of the systemic treatments) on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. CT C/A/P every 2 months. A window of +/- 3 weeks for scans is allowed in order to accommodate patient schedules.
Group 2 resectable liver metastases from colorectal cancer
- Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. Treatment will continue for 6 months in the absence of toxicity or patient withdrawal. CT C/A/P every 3 months. A window of +/- 3 weeks for scans is allowed in order to accommodate patient schedules.
Group 3 unresectable cholangiocarcinoma
- Patients will receive Gemcitabine (800 mg/m2 IV over 30 minutes) and Oxaliplatin (85 mg/ m2 IV over 120 minutes) or Gemcitabine (1000 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. A CT C/A/P every 2 months during treatment. A window of +/- 3 weeks for scans is allowed in order to accommodate patient schedules.
- Conditions
- Colorectal Cancer, Cholangiocarcinoma
- Being tested
- Medtronic pump and Codman catheter, Floxuridine (FUDR), Gemcitabine, Oxaliplatin, Irinotecan (CPT-11)
- Keywords
- Medtronic Pump, Codman Catheter, Hepatic Arterial Infusion (HAI), Floxuridine (FUDR), Gemcitabine, Oxaliplatin, Irinotecan (CPT-11), Fluorouracil, Leucovorin Calcium (Folinic Acid), Dexamethasone, 18-343
- Medical subject headings
- Colorectal Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic pump and Codman catheterDevice
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
Floxuridine (FUDR)Drug
Please see Detailed Description.
GemcitabineDrug
Please see Detailed Description.
OxaliplatinDrug
Please see Detailed Description.
Irinotecan (CPT-11)Drug
Please see Detailed Description.
FluorouracilDrug
Please see Detailed Description.
Anti-EGFR (Panitumumab or Cetuximab)Drug
Please see Detailed Description.
| Study group | Role | What they receive |
|---|---|---|
| Pump Therapy | Experimental | All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin. Receives: Device: Medtronic pump and Codman catheter; Drug: Floxuridine (FUDR); Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Irinotecan (CPT-11); Drug: Fluorouracil; Drug: Anti-EGFR (Panitumumab or Cetuximab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Requiring Stent Replacements
Measured: 1 year
Number of Participants With Any Grade Liver Toxicity
Alkaline phosphatase, serum bilirubin of any patient that received 2 cycles of pump therapy.
Measured: 1 year
Secondary outcomes (2)
Overall Survival at 1 Year Assessed as the Number of Participants Who Were Alive or Dead at 1 Year
Overall survival is defined as the time from treatment initiation till the day of death or last follow-up whichever occurs first.
Measured: 1 year
Progression Free Survival
Progression free survival is defined as the time from treatment initiation till the day of progression or death whichever occurs first. Patients that are alive without progression at the end of the study will be censored.
Measured: up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start18 Oct 2018
- Primary completion27 Jun 2024
- Study completion27 Jun 2024
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.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot non- randomized safety study.
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Kemeny, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03693807
- Sponsor's protocol ID
- 18-343
- Status last verified
- Jun 2025
- First submitted
- 1 Oct 2018
- Last updated
- 6 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Protocol Evaluating Safety of Using the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With Colorectal Carcinoma or Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT03693807
- Acronym / sponsor ID
- 18-343
- Conditions
- Colorectal Cancer, Cholangiocarcinoma
- Keywords
- Medtronic Pump, Codman Catheter, Hepatic Arterial Infusion (HAI), Floxuridine (FUDR), Gemcitabine, Oxaliplatin, Irinotecan (CPT-11), Fluorouracil
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 27 Jun 2024 (actual)
- Study completion
- 27 Jun 2024 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Posted 6 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to answer the following question:
Is the combination of the Medtronic pump and the Codman catheter device a safe alternative to the C3000 Codman pump for delivering chemotherapy directly into the liver of patients with metastatic colorectal cancer or cholangiocarcinoma?
Detailed description
Group 1 unresectable liver metastases from colorectal cancer
- Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin (anti- EGFR agent may be added to any of the systemic treatments) on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. CT C/A/P every 2 months. A window of +/- 3 weeks for scans is allowed in order to accommodate patient schedules.
Group 2 resectable liver metastases from colorectal cancer
- Patients will receive either FOLFIRI, FOLFOX, Irinotecan or Irinotecan/oxaliplatin on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. Treatment will continue for 6 months in the absence of toxicity or patient withdrawal. CT C/A/P every 3 months. A window of +/- 3 weeks for scans is allowed in order to accommodate patient schedules.
Group 3 unresectable cholangiocarcinoma
- Patients will receive Gemcitabine (800 mg/m2 IV over 30 minutes) and Oxaliplatin (85 mg/ m2 IV over 120 minutes) or Gemcitabine (1000 mg/m2 IV over 30 minutes) alone on Days 1 and 15 of each cycle, however initiation with systemic chemotherapy will not take place until 4 weeks post-surgery for pump placement, so the first doses of systemic chemotherapy will be given on Cycle 1, Day 15, and then every 2 weeks thereafter. A CT C/A/P every 2 months during treatment. A window of +/- 3 weeks for scans is allowed in order to accommodate patient schedules.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot non- randomized safety study.
| Arm | Type | Receives |
|---|---|---|
| Pump Therapy | Experimental | Device: Medtronic pump and Codman catheter, Drug: Floxuridine (FUDR), Drug: Gemcitabine, Drug: Oxaliplatin, Drug: Irinotecan (CPT-11), Drug: Fluorouracil, Drug: Anti-EGFR (Panitumumab or Cetuximab)All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinicalyl or radiographically confirmed extrahepatic disease (or) Histologically confirmed cholangiocarcinoma (Clinical or radiographic evidence of metastatic disease that has been resected is allowed, provided there is no recurrence in that area prior to protocol consent)
- Confirmation of diagnosis must be performed at MSKCC
- Patient may have completely resected hepatic metastases without current evidence of other metastatic disease
- Lab values ≤14 days prior to registration:
- Prior chemotherapy is acceptable if last dose given ≥3 weeks prior to registration to this study. [Note: no chemotherapy to be given after resection of liver lesions prior to treatment on this study]
Key exclusion criteria (12 listed)
- Prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if competed at least 4 weeks prior to the planned first dose of treatment on protocol)
- Active infection, ascites, hepatic encephalopathy
- 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 treatment start)
- If in the opinion of the treating investigator a patient has any serious medical problems which may preclude receiving this type of treatment
- Patients with current evidence of hepatitis A, B, C (i.e., active hepatitis)
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 pump and Codman catheterAll patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin. | Device | Pump Therapy |
| Floxuridine (FUDR)Please see Detailed Description. | Drug | Pump Therapy |
| GemcitabinePlease see Detailed Description. | Drug | Pump Therapy |
| OxaliplatinPlease see Detailed Description. | Drug | Pump Therapy |
| Irinotecan (CPT-11)Please see Detailed Description. | Drug | Pump Therapy |
| FluorouracilPlease see Detailed Description. | Drug | Pump Therapy |
| Anti-EGFR (Panitumumab or Cetuximab)Please see Detailed Description. | Drug | Pump Therapy |
Primary outcome
Number of Patients Requiring Stent Replacements
Time frame: 1 year
Number of Participants With Any Grade Liver Toxicity
Time frame: 1 year
Alkaline phosphatase, serum bilirubin of any patient that received 2 cycles of pump therapy.
2 secondary outcomes
Overall Survival at 1 Year Assessed as the Number of Participants Who Were Alive or Dead at 1 Year
Time frame: 1 year
Progression Free Survival
Time frame: up to 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Nancy Kemeny, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medtronic pump and Codman catheter, Floxuridine (FUDR) and Gemcitabine in people with Colorectal Cancer and Cholangiocarcinoma, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 13 inclusion and 12 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: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2026). 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?
Number of Patients Requiring Stent Replacements (time frame: 1 year). The study lists 2 primary outcomes in all. 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 6 Feb 2026.