Medtronic Pump and Codman Catheter in Delivering Chemotherapy Directly to the Liver in Patients with Metastatic Colorectal Cancer or Cholangiocarcinoma

Status: Active

Description

This phase II trial studies the side effects of a Medtronic pump and Codman catheter when used to deliver chemotherapy directly to the liver in patients with cholangiocarcinoma or colorectal cancer that has spread to other places in the body. The Medtronic pump and Codman catheter are devices that are surgically placed in the liver and used to deliver treatment directly to tumor cells which may help to shrink the tumor. Drugs used in chemotherapy, such as floxuridine and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Using the Medtronic pump and Codman catheter to deliver chemotherapy may work better in treating patients with colorectal cancer or cholangiocarcinoma.

Eligibility Criteria

Inclusion Criteria

  • 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)
  • Confirmation of diagnosis must be performed at Memorial Sloan Kettering Cancer Center (MSKCC)
  • Patient may have completely resected hepatic metastases without current evidence of other metastatic disease
  • White blood cell (WBC) >= 2.5 K/uL =< 14 days prior to registration
  • Platelets >= 100,000/uL =< 14 days prior to registration
  • Creatinine < 1.7 mg/dL =< 14 days prior to registration
  • Hemoglobin (HGB) >= 8.5 gm/dL =< 14 days prior to registration
  • Total bilirubin =< 1.5 mg/dl =< 14 days prior to registration
  • Prior chemotherapy is acceptable if last dose of oxaliplatin or irinotecan is given >= 3 weeks prior to planned first dosing on this protocol; fluorouracil (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
  • Any investigation agent is acceptable if administered >= 3 months before planned first dose on this protocol
  • Karnofsky performance status (PS) >= 60%

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 central nervous system (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: * 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 * Adequately treated non-melanomatous skin cancer or lentigo maligna without evidence of disease * Adequately treated cervical carcinoma in situ without evidence of disease

Locations & Contacts

New Jersey

Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Nancy Ellen Kemeny
Phone: 646-888-4180
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Nancy Ellen Kemeny
Phone: 646-888-4180
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Nancy Ellen Kemeny
Phone: 646-888-4180

New York

Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Nancy Ellen Kemeny
Phone: 646-888-4180
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Nancy Ellen Kemeny
Phone: 646-888-4180
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Nancy Ellen Kemeny
Phone: 646-888-4180
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Nancy Ellen Kemeny
Phone: 646-888-4180

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the safety of using the Medtronic pump with the Codman catheter for hepatic arterial infusion (HAI) to deliver chemotherapy to patients with colorectal cancer that is metastatic (unresectable or resectable) and cholangiocarcinoma.

SECONDARY OBJECTIVES:

I. To measure overall survival (OS) and progression free survival.

OUTLINE:

Patients undergo surgical implantation of Medtronic pump and Codman catheter into the liver. Within 14 days of surgery, patients receive floxuridine, dexamethasone, heparin, and saline via Medtronic pump and Codman catheter on day 1. After pump is emptied, patients receive heparin and saline via Medtronic pump and Codman catheter on day 15. Patients also receive standard chemotherapy at the discretion of the treating physician on day 15 of course 1 and on days 1 and 15 of subsequent courses. Courses repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Memorial Sloan Kettering Cancer Center

Principal Investigator
Nancy Ellen Kemeny

Trial IDs

Primary ID 18-343
Secondary IDs NCI-2018-02466
Clinicaltrials.gov ID NCT03693807