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 Using the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in Patients With 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, 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 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

35

Start Date

October 18, 2018

Completion Date

September 2021

Primary Completion Date

September 2021

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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Nancy Kemeny, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03693807

Organization ID

18-343


Responsible Party

Sponsor

Study Sponsor

Memorial Sloan Kettering Cancer Center


Study Sponsor

Nancy Kemeny, MD, Principal Investigator, Memorial Sloan Kettering Cancer Center


Verification Date

July 2020