A Study of the Use of the Medtronic Pump and Codman Catheter to Give Chemotherapy to Patients With Colorectal Carcinoma or Cholangiocarcinoma

NCT ID: NCT03693807

Last Updated: 2026-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-18
• Study Completion Date: 2024-06-27

Brief 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?

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pump Therapy

All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.

Group Type: EXPERIMENTAL

Medtronic pump and Codman catheter

Intervention Type: DEVICE

All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.

Floxuridine (FUDR)

Intervention Type: DRUG

Please see Detailed Description.

Gemcitabine

Intervention Type: DRUG

Please see Detailed Description.

Oxaliplatin

Intervention Type: DRUG

Please see Detailed Description.

Irinotecan (CPT-11)

Intervention Type: DRUG

Please see Detailed Description.

Fluorouracil

Intervention Type: DRUG

Please see Detailed Description.

Anti-EGFR (Panitumumab or Cetuximab)

Intervention Type: DRUG

Please see Detailed Description.

Interventions

Medtronic pump and Codman catheter

All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.

Intervention Type: DEVICE

Floxuridine (FUDR)

Please see Detailed Description.

Intervention Type: DRUG

Gemcitabine

Please see Detailed Description.

Intervention Type: DRUG

Oxaliplatin

Please see Detailed Description.

Intervention Type: DRUG

Irinotecan (CPT-11)

Please see Detailed Description.

Intervention Type: DRUG

Fluorouracil

Please see Detailed Description.

Intervention Type: DRUG

Anti-EGFR (Panitumumab or Cetuximab)

Please see Detailed Description.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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
• Serious or non-healing active wound, ulcer, or bone fracture
• History of other malignancy, except:

1. 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

2. Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease

3. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy Kemeny, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.mskcc.org/mskcc/html/44.cfm

Memorial Sloan Kettering Cancer Center

Other Identifiers

18-343

Identifier Type: -

Identifier Source: org_study_id