A Single-Arm Phase II Study of Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver

STATUS

Recruiting
End date

Dec 30, 2030
participants needed

40
sponsor

National Cancer Institute (NCI)

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Updated on 27 October 2022

See if I qualify

cancer

blood tests

fluorouracil

blood test

dexamethasone

metastasis

oxaliplatin

chemotherapy drug

neutrophil count

liver metastasis

irinotecan

metastatic colorectal cancer

cetuximab

floxuridine

solid tumors

chemotherapy drugs

systemic chemotherapy

solid tumour

hepatic arterial infusion

solid neoplasm

Summary

Background

Many people with colorectal cancer get liver metastases. Standard treatment for this is a combination of chemotherapy drugs. Directing the chemotherapy to the liver may be effective. A device that does this a pump that delivers drugs over 2 weeks at constant rate into the hepatic artery. The person s body temperature causes the drug to flow from the pump. Researchers want to see if this helps people with colorectal metastases to the liver.

Objective

To study the effectiveness of a hepatic artery infusion pump at treating colorectal metastases to the liver.

Eligibility

Adults at least 18 years old with colorectal metastases to the liver

Design

Participants will be screened with:

Medical history

Physical exam

Heart, blood, and urine tests

Scans

Participants will stay in the hospital a few days. A small plastic tube (catheter) will be inserted in an artery into the liver. The catheter will be attached to the pump. That will lie under the skin on the abdomen. It will be small and participants will be able to feel it.

Participants will get treatment in 28-day cycles.

Every Day 1, they will have physical exam, symptom review, and blood tests.

Every 2 weeks, they will come to the clinic to get chemotherapy by a catheter or port.

Every 12 weeks, they will have a scan.

Tissue samples may be taken during the study.

When they finish the drug, participants may have the pump removed. They will repeat the Day 1 tests. They will be called every 6 months to see how they are doing.

Sponsoring Institute: National Cancer Institute

Description

Background

Nearly 60% of patients with colorectal cancers will develop liver metastases over the course of their disease.
Of patients with metastatic colorectal cancer, the liver will be the sole site of recurrence or the survival-limiting site of disease for 20%.
Liver directed therapy, which has taken many forms over the last several decades, is a potential means to prolong survival for properly selected patients and delay progression at that site.
Hepatic artery infusion of floxuridine (FUDR) via an implantable hepatic artery infusion pump (HAIP) induces objective clinical response rates of nearly 50% in heavily pretreated patients with metastatic colorectal cancer to the liver.
The identification of patients likely to respond to HAIP and those likely to suffer pumprelated adverse events is currently unknown, and has limited the wide-spread adoption of this otherwise well tolerated intervention.

Objective

-To assess the safety of hepatic artery infusion therapy using the Medtronic pump with the

Codman catheter.

To determine the response rate in patients with unresectable metastatic colorectal cancer treated with HAIP chemotherapy as measured by RECIST.

Eligibility
Histologically or cytologically confirmed colorectal adenocarcinoma metastatic to the liver.
Patients with liver metastases not amenable to resection to No Evidence of Disease (NED) in one stage.
Patients must have received systemic chemotherapy.
Age greater than or equal to 18 years.

Design
Single arm, phase II study of HAIP chemotherapy.

Details

Condition	Colorectal Cancer, Liver Metastases, Colorectal Adenocarcinoma, Colorectal Cancer With Hepatic Metastases, Colorectal Carcinoma
Treatment	Panitumumab, Cetuximab, Irinotecan, Oxaliplatin, Leucovorin, 5-fluorouracil, floxuridine, 5FU, Medtronic pump and Codman catheter, OneRNA, FUDR-Dex, HAIP, Medtronic SynchroMed II Pump with Codman 3000 Constant Flow Pump Catheter, HAIP installation, Codman 3000 constant flow pump catheter, Medtronic SynchroMed II Pump
Clinical Study Identifier	NCT03366155
Sponsor	National Cancer Institute (NCI)
Last Modified on	27 October 2022

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Patients must have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma, confirmed by the Laboratory of Pathology, NCI
	Patients must have measurable liver metastatic disease
	Patients must have progressed on, been intolerant of or have residual disease after oxaliplatin- or irinotecan-containing, fluorouracil-based, chemotherapeutic regimen
	Age greater than or equal to 18 years
	ECOG performance status less than or equal to 1
	Patients must have adequate organ and marrow function as defined below
	leukocytes > 3,000/mcL
	absolute neutrophil count > 1,500/mcL
	platelets > 90,000/mcL
	total bilirubin < 1.5 X institutional upper limit of normal
	AST(SGOT)/ALT(SGPT) < 2.5 X institutional upper limit of normal
	creatinine within normal institutional limits OR eGFR within normal as predicted by the CKD-EPI equation > 60 mL/min/1.73 m2
	The hepatic artery infusion pump chemotherapy has potential teratogenic and/or
	Arterial anatomy on CT angiogram amenable to placement of the HAIP
	abortifacient effects. For this reason, women of child-bearing potential and
	Ability of subject to understand and the willingness to sign a written informed consent document
	men must agree to use adequate contraception (hormonal or barrier method of
	HIV-positive patients may be considered for this study only after consultation with an HIV trained physician
	birth control; abstinence) prior to study entry, for the duration of study
	Patients must agree to co-enroll on the Surgical Oncology Program s tissue collection protocol 13C0176, 'Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors'
	participation and for 3 months after completion of study treatment. Should a
	woman become pregnant or suspect she is pregnant while she or her partner is
	participating in this study, she should inform her treating physician
	immediately
Exclusion Criteria
	Patients with liver metastases amenable to resection to No Evidence of Disease (NED) in one stage
	Patients who are receiving any other investigational agents
	Patients with incontrovertible radiographic evidence of disease outside of the colon/rectum (primary) and liver given unlikelihood of benefit from liver-directed therapy
	Note: The exception to this exclusion is patients with fewer than five lung lesions greater
	than 1 cm that have not increased in size by more than 10% over a 4-month period of time
	MSI-high patients who need to be treated with a check-point inhibitors
	and are amenable to resection should subsequent problematic growth occur. Lesions less than
	cm are indeterminant as far as etiology is concerned and will be ignored. Patients with
	liver metastases and oligometastatic lung lesions (we define oligometastatic as less than 5
	Prior radiation to liver
	amen ble to thoracoscopic removal) are still likely to benefit from liver directed therapy
	Patients who have undergone extra-hepatic metastasectomy and have a documented
	disease-free interval less than or equal to 4 months
	Uncontrolled intercurrent illness including, but not limited to, ongoing or active
	infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
	arrhythmia, or psychiatric illness/social situations that would limit compliance with
	study requirements. This also includes any condition, including the presence of
	laboratory abnormalities, which in the opinion of the Principal Investigator places
	the subject at unacceptable risk if they were to participate in the study or confounds
	the ability to interpret data from the study
	Active concurrent malignancies within the last five years other than colorectal
	primary except basal cell skin carcinoma and thyroid carcinoma
	Pregnant women are excluded from this study because of the potential for teratogenic
	or abortifacient effects of the HAIP chemotherapy. Because there is an unknown but
	potential risk for adverse events in nursing infants secondary to treatment of the
	mother with HAIP, breastfeeding should be discontinued if the mother is treated. These
	potential risks may also apply to other agents used in this study
	Patients with active Hepatitis B or C infection because of the potential for increased
	liver toxicity given the damaging effects of the virus
	History of allergic reactions attributed to compounds of similar chemical composition
	to FUDR or heparin

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A Single-Arm Phase II Study of Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver