Study on Using Medtronic Pump and Codman Catheter for Chemotherapy in Patients with Colorectal or Bile Duct Cancer

Sponsor: Benaroya Research Institute

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04668976

Provider View

This clinical trial is testing whether a combination of the Medtronic pump and Codman catheter is a safe way to deliver chemotherapy directly to the liver in patients with colorectal cancer or bile duct cancer that has spread to the liver.

Patient Parameters

Program Overview

The purpose of this study is to find out if using the Medtronic pump and Codman catheter together is a safe alternative to the C3000 Codman pump for delivering chemotherapy directly into the liver for patients with metastatic colorectal cancer or cholangiocarcinoma (bile duct cancer).

Description

This study involves three groups of patients:

  • Group 1: Patients with colorectal cancer that has spread to the liver and cannot be removed by surgery. They will receive chemotherapy treatments such as FOLFIRI, FOLFOX, Irinotecan, or Irinotecan/oxaliplatin on Days 1 and 15 of each cycle. An anti-EGFR agent may be added to these treatments. Chemotherapy will start 4 weeks after surgery to place the pump.

  • Group 2: Patients with colorectal cancer that has spread to the liver but can be removed by surgery. They will receive the same chemotherapy options as Group 1 on Days 1 and 15 of each cycle, starting 4 weeks after surgery for pump placement.

  • Group 3: Patients with bile duct cancer that cannot be removed by surgery. They will receive Gemcitabine and Oxaliplatin or Gemcitabine alone on Days 1 and 15 of each cycle. Chemotherapy will start 4 weeks after surgery for pump placement.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of colorectal cancer that has spread to the liver or bile duct cancer, with no cancer outside the liver.
  • Diagnosis must be confirmed at VMMC.
  • May have had liver metastases removed with no current evidence of other cancer spread.
  • Meet specific lab test values within 14 days before joining the study:
    • 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
    • Total Bilirubin 0 to < 1.2 x reference value
  • Previous chemotherapy is allowed if the last dose was given at least 3 weeks before starting this study.
  • Any investigational drug must have been given at least 3 months before starting this study.
  • ECOG performance status of 0 or 1.
  • Must be 18 years or older.

Exclusion Criteria

  • Previous radiation to the liver (radiation to the pelvis is allowed if completed at least 4 weeks before starting this study).
  • Colorectal cancer with BRAF mutation or mismatch repair defect.
  • Active infection, fluid buildup in the abdomen, or liver-related brain issues.
  • Women who are pregnant, breastfeeding, or planning to become pregnant within 6 months after treatment.
  • Serious medical conditions that may prevent receiving this treatment.
  • Current active hepatitis A, B, or C.
  • History of brain tumors, uncontrolled seizures, or stroke.
  • Serious or non-healing wounds, ulcers, or bone fractures.
  • History of other cancers, except:
    • Cancer treated with curative intent and no active disease for at least 3 years.
    • Adequately treated non-melanoma skin cancer or lentigo maligna.
    • Adequately treated cervical carcinoma in situ.

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