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

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Brief Title

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

Official Title

A Pilot Protocol Evaluating Safety of the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With Advanced Colorectal Carcinoma or Cholangiocarcinoma

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.

      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.

      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.
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of patients requiring stent replacements

Secondary Outcome

 Overall survival

Condition

Colorectal Cancer

Intervention

Medtronic pump and Codman catheter

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

100

Start Date

November 25, 2020

Completion Date

December 2024

Primary Completion Date

December 2023

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Hagen Kennecke, MD, 206-223-6193, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04668976

Organization ID

CRP19045


Responsible Party

Sponsor

Study Sponsor

Benaroya Research Institute

Collaborators

 Virginia Mason Hospital/Medical Center

Study Sponsor

Hagen Kennecke, MD, Principal Investigator, Virginia mason medical Center


Verification Date

December 2020