CClinicalTrials.gg
Sign In
CompletedNCT03366155Updated Aug 28, 2026Results posted

Hepatic Artery Infusion Pump Chemotherapy With Floxuridine and Dexamethasone in Combination With Systemic Chemotherapy for Patients With Colorectal Cancer Metastatic to the Liver

A Phase 2 interventional study of Codman 3000 constant flow pump catheter and Panitumumab in Colorectal Cancer, Liver Metastases and Colorectal Adenocarcinoma, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-28.

Sponsored by National Cancer Institute (NCI) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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 pre-treated 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 the Response Evaluation Criteria in Solid Tumors (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.

02

Conditions studied

  • Colorectal Cancer
  • Liver Metastases
  • Colorectal Adenocarcinoma
  • Colorectal Cancer With Hepatic Metastases
  • Colorectal Carcinoma

Keywords

  • Unresectable Liver Tumor
  • Response Rates
  • Progression-Free Survival
  • Patient Survival
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients must have histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma.
  • 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.
  • Eastern Cooperative Oncology Group (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
    • Aspartate aminotransferase (AST) Serum glutamic oxaloacetic transaminase (SGOT)/Alanine transaminase (ALT) Serum glutamic-pyruvic transaminase (SGPT) \< 2.5 X institutional upper limit of normal
    • creatinine within normal institutional limits OR estimated glomerular filtration rate (eGFR) within normal as predicted by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation > 60 mL/min/1.73 m\^2.
  • The hepatic artery infusion pump chemotherapy has potential teratogenic and/or abortifacient effects. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and after completion of study treatment : 3 months after the last study drug for men; 6 months after the last study drug for women. 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.
  • Arterial anatomy on computed tomography (CT) angiogram amenable to placement of the Hepatic Artery Infusion Pump (HAIP).
  • Ability of subject to understand and the willingness to sign a written informed consent document.
  • Human immunodeficiency virus (HIV)-positive patients may be considered for this study only after consultation with an HIV trained physician.
  • Patients must agree to co-enroll on the Surgical Oncology Programs tissue collection protocol 13C0176, 'Tumor, Normal Tissue and Specimens from Patients Undergoing Evaluation or Surgical Resection of Solid Tumors'

Exclusion criteria

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, and are amenable to resection should subsequent problematic growth occur. Lesions less than 1 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 amenable 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.
  • Microsatellite Instability (MSI)-high patients who need to be treated with check-point inhibitors
  • 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.
  • Prior radiation to liver.
  • 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, breast-feeding should be discontinued if the mother is treated. These potential risks may also apply to other agents used in this study. Lactating women must-not breastfeed during study treatment and until at least 7 days after the final dose of study drug(s).
  • 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 floxuridine (FUDR) or heparin.
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    1/ Arm 1: Hepatic Artery Infusion Pump (HAIP) Chemotherapy + Systemic Chemotherapy

    HAIP chemotherapy + Systemic chemotherapy

    Device: Codman 3000 constant flow pump catheter · Drug: Panitumumab · Drug: FUDR-Dex · Drug: Oxaliplatin · Drug: 5FU · Drug: Irinotecan · Procedure: HAIP installation · Drug: cetuximab · Device: Medtronic SynchroMed II Pump · Drug: Floxuridine · Drug: Dexamethasone · Diagnostic Test: EKG · Diagnostic Test: CT C/A/P · Diagnostic Test: CT Angiogram (abdomen) · Procedure: Tumor and normal liver biopsy · Drug: Leucovorin

Interventions

  • DeviceCodman 3000 constant flow pump catheter

    Implanted Medtronic SynchroMed II Pump with codman 3000 Constant Flow Pump Catheter

  • DrugPanitumumab

    6 mg/kg, intravenous (IV)

    Also known as: Vectibix

  • DrugFUDR-Dex

    Hepatic Artery Infusion Pump (HAIP) will be filled with mixture of Floxuridine and Dexamethasone. Pump will perfuse drugs to liver for 14 days. Floxuridine (0.12 mg/kg X pump volume X pump flow rate), Dexamethasone (1 mg/day X pump volume (30) X pump flow rate)

    Also known as: Floxuridine and Dexamethasone

  • DrugOxaliplatin

    85 mg/m\^2, intravenous (IV)

    Also known as: Eloxatin

  • Drug5FU

    2000 mg/m\^2, intravenous (IV) 46-hour infusion of 5-Fluorouracil + 400 mg/m\^2, IV of Leucovorin

    Also known as: 5-Fluorouracil

  • DrugIrinotecan

    150 mg/m\^2, intravenous (IV)

    Also known as: Camptosar, Onivyde

  • ProcedureHAIP installation

    Hepatic Artery Infusion (HAI) pump installation

    Also known as: Hepatic Artery Infusion Pump (HAIP) installation

  • Drugcetuximab

    500 mg/m\^2, intravenous (IV)

    Also known as: Erbitux

  • DeviceMedtronic SynchroMed II Pump

    Implanted Medtronic SynchroMed II Pump with Codman 3000 Constant Flow Pump Catheter

  • DrugFloxuridine

    Floxuridine 0.12 mg/kg X pump volume X pump flow rate

    Also known as: 5-fluorodeoxyuridine

  • DrugDexamethasone

    1 mg/day X pump volume (30) X pump flow rate

    Also known as: Decadron

  • Diagnostic testEKG

    Screening and baseline.

    Also known as: Electrocardiogram

  • Diagnostic testCT C/A/P

    Screening, baseline and Cycle 1. One cycle is 28 (+/- 2 days).

    Also known as: Computed tomography chest, abdomen, pelvis

  • Diagnostic testCT Angiogram (abdomen)

    Screening

    Also known as: Computed tomography angiogram (abdomen)

  • ProcedureTumor and normal liver biopsy

    For research: During surgery to install pump, time of progression per principal investigator discretion if safe, and end of treatment.

    Also known as: Tumor and normal liver bx

  • DrugLeucovorin

    400 mg/m\^2, intravenous (IV), (Day15, Day1)

    Also known as: folinic acid

05

What researchers measure

Primary outcomes

  1. Response Rate (RR) Reported With an 80% Confidence Interval

    Response rate is defined as the number of participants who experience a partial response (PR) or complete response (CR) using the study treatment was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) and reported with an 80% confidence interval. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

    Time frame: 6 months

  2. Response Rate (RR) Reported With a 95% Confidence Interval

    Response rate is defined as the percentage of participants who experience a partial response (PR) or complete response (CR) using the study treatment determined by dividing the number of responders by the total evaluable participants. RR was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and reported with an 95% confidence interval. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

    Time frame: 6 months

  3. Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency

    Safety was determined by grade 1, 2, 3, 4, and/or 5 serious and/or non-serious adverse events with type and frequency assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.

    Time frame: 30 days

Secondary outcomes

  1. Overall Survival

    OS is defined as the median amount of time a participant survives after therapy determined using the Kaplan Meier method. The 95% confidence intervals were obtained using the Brookmeyer-Crowley method via a log-log (complementary log-log) transformation. As pre-specified in the protocol Statistical Section 10.4.3 Analysis of the Secondary Efficacy Endpoints, Overall survival (OS) will be calculated "from the date the patient enrolled onto the trial." The Responsible Party's rationale for reporting a different time frame is "The RP's preference is to report from the date of pump insertion given the time variability from enrollment to surgery, which is a function of operating room (OR) availability, and nothing related to the study.

    Time frame: Date of Hepatic Artery Infusion Pump (HAIP) insertion through death or study completion, up to 63.1 months

  2. Intra-Hepatic Progression-free Survival (PFS)

    Intrahepatic PFS is defined as the duration of time from date of operation to the date of first observation of progressive disease within the liver or death, whichever comes first. Progression was measured by the Response Evaluation Criteria in Solid Tumors and determined using the Kaplan Meier method. Progression is at least a 20% increase in the sum of the diameters of target lesions. The 95% confidence intervals were obtained using the Brookmeyer-Crowley method via a log-log (complementary log-log) transformation. As prespecified in the protocol Statistical Section 10.4.3 Intra-hepatic PFS will be calculated "from the date the patient enrolled onto the trial." The Responsible Party's (RP) rationale for reporting a different time frame is "The RP's preference is to report from the date of pump insertion given the time variability from enrollment to surgery, which is a function of operating room (OR) availability, and nothing related to the study.

    Time frame: Date of hepatic artery infusion pump (HAIP) insertion through either the date of first hepatic progression or study completion, up to 63.1 months

  3. Extra-hepatic Progression-free Survival (PFS)

    Extra-hepatic PFS is defined as the duration of time from date of operation to the date of first observation of progressive disease outside of the liver or death, whichever comes first. Extra-hepatic PFS was determined using the KaplanMeier method\&reported with a 95% confidence interval. Progression was measured by the Response Evaluation Criteria in Solid Tumors. Progression is at least a 20% increase in the sum of the diameters of target lesions. The 95% confidence intervals were obtained using the Brookmeyer-Crowley method via a log-log(complementary log-log) transformation. As prespecified in the protocol Statistical Section 10.4.3Extra-hepatic PFS will be calculated "from the date the patient enrolled onto the trial." The Responsible Party's((RP) rationale for reporting a differently is "RP's preference is to report from the date of pump insertion given the time variability from enrollment to surgery,which is a function of operating room availability\&nothing related to the study.

    Time frame: Date of hepatic artery infusion pump (HAIP) insertion through either the date of first extra-hepatic progression or study completion, up to 63.1 months

Other outcomes

  1. Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

    Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

    Time frame: Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months

06

Results

Posted Aug 28, 2026

Participant flow

Participant flow — Overall Study
MilestoneHepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
Started24
Enrolled24
Intraoperative screen failures2
Completed ≥ 1 cycle of treatment22
Autoimmune disease not comparable with nct052868141
Lost to follow-up1
Final cohort of treated participants20
Completed20
Not completed4
Withdrew: Participants deemed ineligible after signing consent1
Withdrew: Did not receive treatment.2
Withdrew: Physician decision1

Outcome measures

PrimaryResponse Rate (RR) Reported With an 80% Confidence Interval

Response rate is defined as the number of participants who experience a partial response (PR) or complete response (CR) using the study treatment was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) and reported with an 80% confidence interval. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Time frame:
6 months
Reported as:
Number · percentage of participants
Response Rate (RR) Reported With an 80% Confidence Interval
percentage of participantsHepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
Partial Response25 (12.7 to 41.5)
Complete Response10 (2.7 to 24.5)
Statistical analysis
  • Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo · Clopper-pearson exact binomial methods: 25 · 80% CI 12.7 to 41.5The reported estimated value for the estimation parameter is representative of Partial Response at 6 months.
  • Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo · Clopper-pearson exact binomial methods: 10 · 80% CI 2.7 to 24.5The reported estimated value for the estimation parameter is representative of Complete Response at 6 months.
PrimaryResponse Rate (RR) Reported With a 95% Confidence Interval

Response rate is defined as the percentage of participants who experience a partial response (PR) or complete response (CR) using the study treatment determined by dividing the number of responders by the total evaluable participants. RR was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) and reported with an 95% confidence interval. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Complete Response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm.

Time frame:
6 months
Reported as:
Number · percentage of participants
Response Rate (RR) Reported With a 95% Confidence Interval
percentage of participantsHepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
Partial Response25 (8.7 to 49.1)
Complete Response10 (1.2 to 31.7)
Statistical analysis
  • Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo · Clopper-pearson exact binomial methods: 25 · 95% CI 8.7 to 49.1The reported estimated value for the estimation parameter is representative of Partial Response at 6 months.
  • Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo · Clopper-pearson exact binomial methods: 10 · 95% CI 1.2 to 31.7The reported estimated value for the estimation parameter is representative of Complete Response at 6 months.
PrimaryNumber of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency

Safety was determined by grade 1, 2, 3, 4, and/or 5 serious and/or non-serious adverse events with type and frequency assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. Grade 5 is death related to adverse event.

Time frame:
30 days
Reported as:
Number · adverse events
Number of Grade 1, 2, 3, 4, and/or 5 Serious and/or Non-serious Adverse Events Reported With Type and Frequency
adverse eventsGrade 1Grade 2Grade 3Grade 4Grade 5
Abdominal distention: Non-serious01000
Abdominal distension: Serious01000
Abdominal pain: Non-Serious24300
Acidosis: Non-Serious10200
Activated Partial Thromboplastin Time Prolonged: Non-Serious13000
Alanine aminotransferase increased: Non-Serious1252260
Alkaline aminotransferase increased: Non-Serious20000
Alkaline phosphatase increased: Non-Serious216300
Alopecia: Non-Serious10000
Anemia: Non-Serious0412800
Anorexia: Non-Serious10000
Arthralgia: Non-Serious01100
Ascites: Non-Serious11100
Aspartate aminotransferase increased1222290
Atelectasis: Non-Serious12100
Atrial fibrillation: Non-Serious01000
Back pain: Non-Serious10000
Belching: Non-Serious10000
Bloating: Non-Serious01000
Blood bilirubin increased: Non-Serious116400
Bile duct stenosis: Serious00100
Cardiac arrest: Serious00010
Chest pain: Non-Serious01000
Chylothorax: Non-Serious01000
Constipation: Non-Serious01000
CPK increased: Non-Serious01100
Creatinine increased: Non-Serious02000
Device related infection: Non-Serious01000
Device related infection: Serious00200
Diarrhea: Non-Serious16000
Dry eye: Non-Serious01000
Duodenal perforation: Serious00010
Dyspnea: Non-Serious11000
Edema limbs: Non-Serious10000
Edema trunk: Non-Serious10000
Erectile dysfunction: Non-Serious01000
Fatigue: Non-Serious48100
Fever: Non-Serious03000
Fibrinogen decreased: Non-Serious10000
Flu-like symptoms: Non-Serious01000
Gastritis: Non-Serious01000
Generalized edema: Non-Serious10100
Heart failure: Non-Serious00100
Hematoma: Non-Serious01000
Hemorrhoidal hemorrhage: Non-Serious10000
Hyperhidrosis: Non-Serious01000
Hyperkalemia: Non-Serious01000
Hypertension: Non-Serious04300
Hypoalbuminemia: Non-Serious016200
Hypokalemia: Non-Serious00500
Hypotension: Non-Serious04300
Hypoxia: Non-Serious02300
Infections and infestations - Other, specify (Influenza A): Non-Serious01000
Infusion-related reaction: Non-Serious02000
injury,poisoning and procedural complications,Other,specify (abdominal fluid collection):Non-Serious01000
INR increased: Non-Serious15000
Insomnia: Non-Serious01000
Intra-abdominal hemorrhage: Non-Serious00100
Lymphocyte count decreased: Non-Serious09320
Mania: Non-Serious00100
Mucositis oral: Non-Serious02100
Muscle weakness lower limb: Non-Serious01000
Nausea: Non-Serious22000
Neutrophil count decreased: Non-Serious06210
Non-cardiac chest pain: Non-Serious02100
Otitis media: Non-Serious01000
Pain: Non-Serious12000
Papulopustular rash: Non-Serious12000
Pericardial effusion00000
Peripheral sensory neuropathy02000
Platelet count decreased: Non-Serious06300
Pleural effusion: Non-Serious22100
Pleural effusion: Serious00100
Pleuritic pain: Non-Serious10000
Pneumothorax: Non-Serious00100
Premature menopause: Non-Serious01000
Pruritis: Non-Serious11000
Pulmonary edema: Serious00100
Rash acneiform: Non-Serious01000
Rash maculopapular: Non-Serious22000
Renal and urinary disorders - Other, specify, (Oliguric renal failure): Non-Serious01000
Renal and urinary disorders - Other, specify, (Ureter injury)00100
Sepsis: Serious00001
Sinus tachycardia: Non-Serious04000
Skin ulceration: Non-Serious00100
Stroke: Serious00001
Syncope: Non-Serious00100
Thromboembolic event: Non-Serious00100
Thromboembolic event: Serious00100
Urinary retention: Non-Serious02000
Urinary tract infection: Non-Serious02000
Vascular disorders - Other, specify (Pseudoaneurysm of the GDA): Serious00010
Weight gain: Non-Serious11000
White blood cell decreased: Non-Serious07300
Wound dehiscence: Serious00100
Wound infection: Non-Serious00200
SecondaryOverall Survival

OS is defined as the median amount of time a participant survives after therapy determined using the Kaplan Meier method. The 95% confidence intervals were obtained using the Brookmeyer-Crowley method via a log-log (complementary log-log) transformation. As pre-specified in the protocol Statistical Section 10.4.3 Analysis of the Secondary Efficacy Endpoints, Overall survival (OS) will be calculated "from the date the patient enrolled onto the trial." The Responsible Party's rationale for reporting a different time frame is "The RP's preference is to report from the date of pump insertion given the time variability from enrollment to surgery, which is a function of operating room (OR) availability, and nothing related to the study.

Time frame:
Date of Hepatic Artery Infusion Pump (HAIP) insertion through death or study completion, up to 63.1 months
Reported as:
Median · Months
Overall Survival
MonthsHepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
Overall Survival17.9 (10.2 to 28.0)
Statistical analysis
  • Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo · Brookmeyer-crowley method via a log-log: 17.9 · 95% CI 10.2 to 28.0
SecondaryIntra-Hepatic Progression-free Survival (PFS)

Intrahepatic PFS is defined as the duration of time from date of operation to the date of first observation of progressive disease within the liver or death, whichever comes first. Progression was measured by the Response Evaluation Criteria in Solid Tumors and determined using the Kaplan Meier method. Progression is at least a 20% increase in the sum of the diameters of target lesions. The 95% confidence intervals were obtained using the Brookmeyer-Crowley method via a log-log (complementary log-log) transformation. As prespecified in the protocol Statistical Section 10.4.3 Intra-hepatic PFS will be calculated "from the date the patient enrolled onto the trial." The Responsible Party's (RP) rationale for reporting a different time frame is "The RP's preference is to report from the date of pump insertion given the time variability from enrollment to surgery, which is a function of operating room (OR) availability, and nothing related to the study.

Time frame:
Date of hepatic artery infusion pump (HAIP) insertion through either the date of first hepatic progression or study completion, up to 63.1 months
Reported as:
Median · Months
Intra-Hepatic Progression-free Survival (PFS)
MonthsHepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
Intra-Hepatic Progression-free Survival (PFS)10.8 (7.1 to 23.1)
Statistical analysis
  • Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo · Brookmeyer-crowley method via a log-log: 10.8 · 95% CI 7.1 to 23.1
SecondaryExtra-hepatic Progression-free Survival (PFS)

Extra-hepatic PFS is defined as the duration of time from date of operation to the date of first observation of progressive disease outside of the liver or death, whichever comes first. Extra-hepatic PFS was determined using the KaplanMeier method\&reported with a 95% confidence interval. Progression was measured by the Response Evaluation Criteria in Solid Tumors. Progression is at least a 20% increase in the sum of the diameters of target lesions. The 95% confidence intervals were obtained using the Brookmeyer-Crowley method via a log-log(complementary log-log) transformation. As prespecified in the protocol Statistical Section 10.4.3Extra-hepatic PFS will be calculated "from the date the patient enrolled onto the trial." The Responsible Party's((RP) rationale for reporting a differently is "RP's preference is to report from the date of pump insertion given the time variability from enrollment to surgery,which is a function of operating room availability\&nothing related to the study.

Time frame:
Date of hepatic artery infusion pump (HAIP) insertion through either the date of first extra-hepatic progression or study completion, up to 63.1 months
Reported as:
Number · percentage of participants
Extra-hepatic Progression-free Survival (PFS)
percentage of participantsHepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
Extra-hepatic Progression-free Survival (PFS)8.1 (5.9 to 13.1)
Statistical analysis
  • Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo · Brookmeyer-crowley method via a log-log: 8.1 · 95% CI 5.9 to 13.1
Other pre-specifiedNumber of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Time frame:
Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months
Reported as:
Count of participants · Participants
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)
ParticipantsHepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)24

Adverse events

Collected over All-Cause Mortality was monitored/assessed from the date of surgery (hepatic artery infusion pump insertion) through the completion date of the study, up to a maximum of 61.2 months. Adverse Events were monitored/assessed from the time of operation through 30 days after the participant was taken off treatment, up to 27.7 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo10/24 (41.7%)7/24 (29.2%)23/24 (95.8%)
Most frequent serious events
Showing 10 of 12
Most frequent serious events
EventHepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
Device related infectionInfections and infestations2/24
Wound dehiscenceInjury, poisoning and procedural complications2/24
Abdominal distensionGastrointestinal disorders1/24
Bile duct stenosisHepatobiliary disorders1/24
Cardiac arrestCardiac disorders1/24
Duodenal perforationGastrointestinal disorders1/24
Pleural effusionRespiratory, thoracic and mediastinal disorders1/24
Pulmonary edemaRespiratory, thoracic and mediastinal disorders1/24
SepsisInfections and infestations1/24
StrokeNervous system disorders1/24
Most frequent other events
Showing 10 of 85
Most frequent other events
EventHepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
Alanine aminotransferase increasedInvestigations20/24
AnemiaBlood and lymphatic system disorders20/24
Aspartate aminotransferase increasedInvestigations20/24
Blood bilirubin increasedInvestigations14/24
HypoalbuminemiaMetabolism and nutrition disorders9/24
Alkaline phosphatase increasedInvestigations8/24
Abdominal painGastrointestinal disorders7/24
FatigueGeneral disorders7/24
HypotensionVascular disorders6/24
Lymphocyte count decreasedInvestigations6/24

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
<=18 years0
Between 18 and 65 years20
>=65 years4
Age, Continuous
Age, Continuous(years)Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
Median51.5 (36 to 71)
Sex: Female, Male
Sex: Female, Male(Participants)Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
Female11
Male13
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
Hispanic or Latino2
Not Hispanic or Latino22
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American2
White20
More than one race0
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(participants)Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
United States24
Prior Chemotherapy
Prior Chemotherapy(Participants)Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
5-fluorouracil (5-FU)20
Oxaliplatin20
Irinotecan9
Prior Bevacizumab
Prior Bevacizumab(Participants)Hepatic Artery Infusion Pump Chemo With Floxuridine&Dexamethasone in Combination With Systemic Chemo
Count of participants12

7 further baseline measures are reported on the registry.

07

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
08

References and documents

Publications

  • Ammori JB, Kemeny NE, Fong Y, Cercek A, Dematteo RP, Allen PJ, Kingham TP, Gonen M, Paty PB, Jarnagin WR, D'Angelica MI. Conversion to complete resection and/or ablation using hepatic artery infusional chemotherapy in patients with unresectable liver metastases from colorectal cancer: a decade of experience at a single institution. Ann Surg Oncol. 2013 Sep;20(9):2901-7. doi: 10.1245/s10434-013-3009-3. Epub 2013 Jun 15. PubMed 23771246 ↗
  • D'Angelica MI, Correa-Gallego C, Paty PB, Cercek A, Gewirtz AN, Chou JF, Capanu M, Kingham TP, Fong Y, DeMatteo RP, Allen PJ, Jarnagin WR, Kemeny N. Phase II trial of hepatic artery infusional and systemic chemotherapy for patients with unresectable hepatic metastases from colorectal cancer: conversion to resection and long-term outcomes. Ann Surg. 2015 Feb;261(2):353-60. doi: 10.1097/SLA.0000000000000614. PubMed 24646562 ↗
  • Cercek A, D'Angelica M, Power D, Capanu M, Gewirtz A, Patel D, Allen P, Fong Y, DeMatteo RP, Jarnagin WR, Kemeny NE. Floxuridine hepatic arterial infusion associated biliary toxicity is increased by concurrent administration of systemic bevacizumab. Ann Surg Oncol. 2014 Feb;21(2):479-86. doi: 10.1245/s10434-013-3275-0. Epub 2013 Oct 24. PubMed 24154839 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 17, 2025
  • Informed consent form · Sep 15, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — All individual participant data (IPD) recorded in the medical record will be shared with intramural investigators upon request.

Supporting information: Study protocol, Sap, Icf

09

Registry details

Key details

Study ID
NCT03366155
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Jonathan Hernandez, M.D. (Principal Investigator, National Cancer Institute (NCI)) — Principal investigator
First posted
Dec 8, 2017
Start date
Jun 24, 2019
Primary completion
Nov 13, 2025
Completion
Nov 13, 2025
Results posted
Aug 28, 2026
Last update
Aug 28, 2026

Study contacts

Jonathan M Hernandez, M.D.
principal investigator · National Cancer Institute (NCI)

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Colorectal Neoplasms→

Other studies from this sponsor

National Cancer Institute (NCI)

Start the discussion