Recruiting
Phase 2

Medtronic Pump & Codman Catheter

Sponsor:

Benaroya Research Institute

Code:

NCT04668976

Conditions

Colorectal Cancer

Cholangiocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Medtronic pump and Codman catheter

Floxuridine (FUDR)

Gemcitabine

Oxaliplatin

Irinotecan (CPT-11)

Study Details

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?

Conditions

Colorectal Cancer

Cholangiocarcinoma

Study ID

NCT04668976

Start date

Nov 25, 2020

Status verified date

Dec, 2020

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinically 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)
2. Confirmation of diagnosis must be performed at VMMC
3. Participant may have completely resected hepatic metastases without current evidence of other metastatic disease
4. Lab values ≤14 days prior to registration:

ANC ≥ 1.0(9)/L Platelet count ≥ 75 (9)/L Creatinine ≤1.8 mg/dL AST 0 to 2x reference value ALK PHOS 0 to < 1.2 x reference value Tot Bili 0 to < 1.2 x reference value
5. Prior chemotherapy is acceptable if last dose of oxaliplatin or irinotecan is given ≥3 weeks prior to planned first dosing on this protocol. 5-FU or 5-FU leucovorin may be given ≥2 weeks prior to planned first dosing on this protocol. \[Note: no chemotherapy to be given after resection of liver lesions prior to treatment on this study\]
6. Any investigation agent is acceptable if administered ≥3 months before planned first dose on this protocol
7. ECOG <=1
8. Participants ≥18 years of age

Exclusion Criteria:

1. 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)
2. Colorectal cancer that is BRAF mutant or defective in mismatch repair.
3. Active infection, ascites, hepatic encephalopathy
4. Female participants who are pregnant or lactating - or planning to become pregnant within 6 months after the end of the treatment (female participants of child-bearing potential must have negative pregnancy test ≤72 hours before treatment start)
5. If in the opinion of the treating investigator a participant has any serious medical problems which may preclude receiving this type of treatment
6. Participants with current evidence of hepatitis A, B, C (i.e., active hepatitis)
7. Participants 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
8. Serious or non-healing active wound, ulcer, or bone fracture
9. 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 malignant without evidence of disease
3. Adequately treated cervical carcinoma in situ without evidence of disease

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Pump Therapy

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

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.

Floxuridine (FUDR)

Please see Detailed Description.

Gemcitabine

Please see Detailed Description.

Oxaliplatin

Please see Detailed Description.

Irinotecan (CPT-11)

Please see Detailed Description.

Fluorouracil

Please see Detailed Description.

Anti-EGFR (Panitumumab or Cetuximab)

Please see Detailed Description.

Primary outcome measure

  • Number of patients requiring stent replacements [ Time Frame: 1 year ]
  • Percent frequency liver toxicity [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Locations

Virginia mason medical Center

Recruiting

Seattle, Washington, United States, 98101

Contacts

Principal Investigator:

Hagen Kennecke, MD

More Information

Sponsor

Benaroya Research Institute

Last update posted

Dec 21, 2020

Last verified

Dec, 2020

Keywords

  • Medtronic Pump
  • Codman Catheter
  • Hepatic Arterial Infusion (HAI)
  • Floxuridine (FUDR)
  • Gemcitabine
  • Oxaliplatin
  • Irinotecan (CPT-11)
  • Fluorouracil
  • Leucovorin Calcium (Folinic Acid)
  • Dexamethasone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Benaroya Research Institute on 2020-12-21.