A Phase 2 interventional study of Medtronic pump and Codman catheter and Floxuridine (FUDR) in Colorectal Cancer and Cholangiocarcinoma, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment
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?
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.
5,600 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 35 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 325 are open to participants now.
Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.
Counted across the registry records on this site, refreshed daily.
Lab values ≤14 days prior to registration:
Exclusion Criteria:
History of other malignancy, except:
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.
All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
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.
Please see Detailed Description.
Please see Detailed Description.
Please see Detailed Description.
Please see Detailed Description.
Please see Detailed Description.
Please see Detailed Description.
Number of Patients Requiring Stent Replacements
Time frame: 1 year
Number of Participants With Any Grade Liver Toxicity
Alkaline phosphatase, serum bilirubin of any patient that received 2 cycles of pump therapy.
Time frame: 1 year
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.
Time frame: 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.
Time frame: up to 3 years
| Milestone | Group 1: Unresectable Liver Metastases From Colorectal Cancer | Group 2: Resectable Liver Metastases From Colorectal Cancer | Group 3: Unresectable Cholangiocarcinoma |
|---|---|---|---|
| Started | 15 | 16 | 4 |
| Completed | 11 | 13 | 2 |
| Not completed | 4 | 3 | 2 |
| Withdrew: Adverse event | 1 | 3 | 1 |
| Withdrew: Physician decision | 1 | 0 | 1 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 |
| Participants | Group 1: Unresectable Liver Metastases From Colorectal Cancer | Group 2: Resectable Liver Metastases From Colorectal Cancer | Group 3: Unresectable Cholangiocarcinoma |
|---|---|---|---|
| Participants requiring stent replacement | 1 | 2 | 1 |
| Participants not requiring stent replacement | 14 | 14 | 3 |
Alkaline phosphatase, serum bilirubin of any patient that received 2 cycles of pump therapy.
| Participants | Group 1: Unresectable Liver Metastases From Colorectal Cancer | Group 2: Resectable Liver Metastases From Colorectal Cancer | Group 3: Unresectable Cholangiocarcinoma |
|---|---|---|---|
| Participants with any grade liver toxicity | 12 | 13 | 3 |
| Participants without any grade liver toxicity | 3 | 3 | 1 |
Overall survival is defined as the time from treatment initiation till the day of death or last follow-up whichever occurs first.
| Participants | Group 1: Unresectable Liver Metastases From Colorectal Cancer | Group 2: Resectable Liver Metastases From Colorectal Cancer | Group 3: Unresectable Cholangiocarcinoma |
|---|---|---|---|
| Alive | 2 | 9 | 1 |
| Dead | 13 | 7 | 3 |
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.
| days | Group 1: Unresectable Liver Metastases From Colorectal Cancer | Group 2: Resectable Liver Metastases From Colorectal Cancer | Group 3: Unresectable Cholangiocarcinoma |
|---|---|---|---|
| Progression Free Survival | 231 (49 to 812) | 261 (49 to 812) | 531 (49 to 812) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group 1: Unresectable Liver Metastases From Colorectal Cancer | 13/15 (86.7%) | 13/15 (86.7%) | 0/15 (0%) |
| Group 2: Resectable Liver Metastases From Colorectal Cancer | 7/16 (43.8%) | 7/16 (43.8%) | 0/16 (0%) |
| Group 3: Unresectable Cholangiocarcinoma | 3/4 (75%) | 3/4 (75%) | 0/4 (0%) |
| Event | Group 1: Unresectable Liver Metastases From Colorectal Cancer | Group 2: Resectable Liver Metastases From Colorectal Cancer | Group 3: Unresectable Cholangiocarcinoma |
|---|---|---|---|
| Death NOSGeneral disorders | 13/15 | 7/16 | 3/4 |
| Abdominal painGastrointestinal disorders | 1/15 | 3/16 | 1/4 |
| FeverGeneral disorders | 0/15 | 1/16 | 1/4 |
| Infections and infestations - Other, specifyInfections and infestations | 0/15 | 2/16 | 1/4 |
| Infections and infestations - Other, specify - GastroenteritisInfections and infestations | 0/15 | 0/16 | 1/4 |
| Wound infectionInfections and infestations | 0/15 | 0/16 | 1/4 |
| AnemiaBlood and lymphatic system disorders | 1/15 | 0/16 | 0/4 |
| Cardiac disorders - Other, specify - Aneurysm of the hepatic arteryCardiac disorders | 1/15 | 0/16 | 0/4 |
| DiarrheaGastrointestinal disorders | 1/15 | 1/16 | 0/4 |
| Duodenal ulcerGastrointestinal disorders | 1/15 | 0/16 | 0/4 |
| Age, Continuous(years) | Group 1: Unresectable Liver Metastases From Colorectal Cancer | Group 2: Resectable Liver Metastases From Colorectal Cancer | Group 3: Unresectable Cholangiocarcinoma | Total |
|---|---|---|---|---|
| Mean | 53 (32 to 78) | 51 (32 to 69) | 62 (39 to 75) | 53 (32 to 78) |
| Sex: Female, Male(Participants) | Group 1: Unresectable Liver Metastases From Colorectal Cancer | Group 2: Resectable Liver Metastases From Colorectal Cancer | Group 3: Unresectable Cholangiocarcinoma | Total |
|---|---|---|---|---|
| Female | 7 | 5 | 3 | 15 |
| Male | 8 | 11 | 1 | 20 |
| Ethnicity (NIH/OMB)(Participants) | Group 1: Unresectable Liver Metastases From Colorectal Cancer | Group 2: Resectable Liver Metastases From Colorectal Cancer | Group 3: Unresectable Cholangiocarcinoma | Total |
|---|---|---|---|---|
| Hispanic or Latino | 2 | 3 | 0 | 5 |
| Not Hispanic or Latino | 12 | 12 | 3 | 27 |
| Unknown or Not Reported | 1 | 1 | 1 | 3 |
| Race (NIH/OMB)(Participants) | Group 1: Unresectable Liver Metastases From Colorectal Cancer | Group 2: Resectable Liver Metastases From Colorectal Cancer | Group 3: Unresectable Cholangiocarcinoma | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 0 | 2 |
| White | 12 | 12 | 4 | 28 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 3 | 0 | 4 |
| Region of Enrollment(Participants) | Group 1: Unresectable Liver Metastases From Colorectal Cancer | Group 2: Resectable Liver Metastases From Colorectal Cancer | Group 3: Unresectable Cholangiocarcinoma | Total |
|---|---|---|---|---|
| United States | 15 | 16 | 4 | 35 |
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Memorial Sloan Kettering Cancer Center