Recruiting

Phase 3

Pump Chemotherapy vs. Standard of CareTesting Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial

Sponsor:

ECOG-ACRIN Cancer Research Group

Code:

NCT05863195

Conditions

Metastatic Colorectal Carcinoma

Metastatic Malignant Neoplasm in the Liver

Stage IV Colorectal Cancer AJCC v8

Unresectable Colorectal Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bevacizumab

Cetuximab

Computed Tomography

Floxuridine

Fluorouracil

Study Details

Brief summary:

This phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is already approved by the Food and Drug Administration (FDA) for use in metastatic colorectal cancer to the liver, but it is only available at a small number of hospitals, and most of the time it is not used until standard chemotherapy stops working. Standard chemotherapy drugs 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. Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing unresectable colorectal liver metastases.

Conditions

Metastatic Colorectal Carcinoma

Metastatic Malignant Neoplasm in the Liver

Stage IV Colorectal Cancer AJCC v8

Unresectable Colorectal Carcinoma

Study ID

NCT05863195

Start date

Oct 19, 2023

Status verified date

Jul, 2026

Completion date

Jun 30, 2034

Anticipated

Primary completion date

Jun 30, 2029

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Patient must be >= 18 years of age
Patient must have confirmed unresectable liver confined metastatic colorectal cancer (CRC).

Patient must not have radiographically or clinically evident extrahepatic disease (including but not limited to radiographically positive periportal lymph nodes).

NOTE: Patients found to have positive periportal nodes at the time of HAI placement can remain on study.
Patient may have calcified pulmonary nodules, and/or =< 5 indeterminate and stable (for a minimum of 3 months on chemotherapy) pulmonary nodules each measuring =< 6 mm in maximal axial dimension.
Patient's primary tumor may be in place.
Patient must have received 3-6 months of previous first-line chemotherapy that meet one of the following three criteria: a) have received at least 6 but no more than 12 cycles of first-line cytotoxic chemotherapy (where 1 cycle = 14 days) OR b) have received at least 4 but no more than 8 cycles of first-line cytotoxic chemotherapy (where 1 cycle = 21 days) OR c) have developed new colorectal liver metastases (CRLM) within 12 months of completing adjuvant systemic therapy for stage II-III colorectal cancer.

NOTE: First-line chemotherapy may have included any of the following regimens as listed in the National Comprehensive Cancer Network (NCCN) Guidelines: leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (FOLFOX) (or equivalent), leucovorin calcium (calcium folinate), 5-fluorouracil, and irinotecan (FOLFIRI) (or equivalent), leucovorin calcium (calcium folinate), 5-fluorouracil, oxaliplatin, and irinotecan (FOLFOXIRI), each with or without any of the following: bevacizumab, cetuximab, or panitumumab.
Patient must have stable or responding disease on first-line chemotherapy by RECIST 1.1 criteria
Patient must meet the following criteria for technical unresectability:

A margin-negative resection requires resection of three hepatic veins, both portal veins, or the retrohepatic vena cava OR a resection that leaves less than two adequately perfused and drained segments.
NOTE: Institutional multidisciplinary review is required to confirm unresectability and rule out radiographically positive extrahepatic disease.
Patient must undergo CT angiography (chest/abdomen/pelvis) to confirm acceptable hepatic arterial anatomy for HAI and to rule out extrahepatic disease within 4 weeks prior to randomization.
Patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 and be clinically fit to undergo surgery as determined by the pre-operative evaluation.
Leukocytes >= 3,000/mcL (obtained =< 14 days prior to protocol randomization)
Absolute neutrophil count (ANC) >= 1,500/mcL (obtained =< 14 days prior to protocol randomization)
Platelets >= 100,000/mcL (obtained =< 14 days prior to protocol randomization)
Total Bilirubin =< 1.5 mg/dL (obtained =< 14 days prior to protocol randomization)
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) =< 3.0 x institutional upper limit of normal (ULN) (obtained =< 14 days prior to protocol randomization)
Creatinine =< 1.5 x institutional ULN OR creatinine clearance >= 50 mL/min calculated by the Cockcroft-Gault method (obtained =< 14 days prior to protocol randomization)
Calcium >= institutional lower limit of normal (LLN)
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. Testing for HIV is not required for entry onto the study

Exclusion Criteria:

Patient must not have a liver tumor burden exceeding 70% of total liver volume.
Patient must not have had prior radiation to the liver (prior radiation therapy to the pelvis is acceptable if completed at least 2 weeks prior to randomization).
Patient must not have had prior trans-arterial bland embolization, chemoembolization (TACE) or radioembolization (TARE).
Patient must not have had prior treatment with HAI/floxuridine (FUDR)
Patient must not have microsatellite instability-high (MSI-H) colorectal cancer.
Patient must not have CRLM that could be resected with 2-stage hepatectomy, including associating liver partition and portal vein ligation (ALPPS).
Patient must not have an active infection, serious or non-healing active wound, ulcer, or bone fracture.
Patient must not have any serious medical problems which would preclude receiving the protocol treatment or would interfere with the cooperation with the requirements of this trial.
Patient must not have cirrhosis and/or clinical or radiographic evidence of portal hypertension
Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used.

All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy.
A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study.

Study Design

Enrollment

408 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A (HAI, floxuridine, standard chemotherapy)

Patients undergo surgery to place the HAI pump, followed by SPECT/CT on study. Patients then receive floxuridine via the HAI pump on study. Patients also receive one of the following standard chemotherapy regimens per the treating physician: FOLFOX, FOLFIRI, or OX/IRI with or without cetuximab IV and/or panitumumab IV on study. Patients also undergo CT scans throughout the trial.

active comparator: Arm B (standard chemotherapy)

Patients receive one of the following standard chemotherapy regimens per the treating physician: FOLFOXIRI, FOLFOX, FOLFIRI, or OX/IRI with or without cetuximab IV, panitumumab IV, and/or bevacizumab IV on study. Patients also undergo CT scans throughout the trial.

Interventions

Bevacizumab

Given IV

Cetuximab

Given IV

Computed Tomography

Undergo SPECT/CT and/or CT

Floxuridine

Given via HAI pump

Fluorouracil

Given IV

Implantation

Undergo surgery to place the HAI pump

Intrahepatic Infusion Procedure

Undergo HAI

Irinotecan

Given IV

Leucovorin

Given IV

Oxaliplatin

Given IV

Panitumumab

Given IV

Single Photon Emission Computed Tomography

Undergo SPECT/CT

Primary outcome measure

Overall survival (OS) [ Time Frame: From randomization to death from any cause, assessed up to 5 years ]

Central Contacts and Locations

Locations

Banner MD Anderson Cancer Center

Recruiting

Gilbert, Arizona, United States, 85234

Contacts

Site Public Contact

602-747-9738

Principal Investigator:

Rajesh Ramanathan

Banner-University Medical Center Phoenix

Recruiting

Phoenix, Arizona, United States, 85006

Contacts

Site Public Contact

BannerResearch@bannerhealth.com

Principal Investigator:

Rajesh Ramanathan

Banner Boswell Medical Center

Recruiting

Sun City, Arizona, United States, 85351

Contacts

Site Public Contact

480-440-7458 BMDACCResearch@bannerhealth.com

Principal Investigator:

Rajesh Ramanathan

UCHealth University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Site Public Contact

720-848-0650

Principal Investigator:

Alexis D. Leal

UM Sylvester Comprehensive Cancer Center at Aventura

Recruiting

Aventura, Florida, United States, 33180

Contacts

Site Public Contact

954-461-2180

Principal Investigator:

Jashodeep Datta

UM Sylvester Comprehensive Cancer Center at Coral Gables

Recruiting

Coral Gables, Florida, United States, 33146

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Jashodeep Datta

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Recruiting

Deerfield Beach, Florida, United States, 33442

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Jashodeep Datta

UM Sylvester Comprehensive Cancer Center at Hollywood

Recruiting

Hollywood, Florida, United States, 33021

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Jashodeep Datta

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, United States, 33136

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Jashodeep Datta

UM Sylvester Comprehensive Cancer Center at Kendall

Recruiting

Miami, Florida, United States, 33176

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Jashodeep Datta

UM Sylvester Comprehensive Cancer Center at Plantation

Recruiting

Plantation, Florida, United States, 33324

Contacts

Site Public Contact

305-243-2647

Principal Investigator:

Jashodeep Datta

Emory University Hospital/Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Site Public Contact

404-778-1868

Principal Investigator:

Olumide B. Gbolahan

Emory Saint Joseph's Hospital

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Site Public Contact

404-851-7115

Principal Investigator:

Olumide B. Gbolahan

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Site Public Contact

312-695-1301 cancer@northwestern.edu

Principal Investigator:

Shishir K. Maithel

University of Chicago Comprehensive Cancer Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Site Public Contact

773-702-8222 cancerclinicaltrials@bsd.uchicago.edu

Principal Investigator:

Ryan Merkow

Northwestern Medicine Cancer Center Old Irving Park

Recruiting

Chicago, Illinois, United States, 60641

Contacts

Site Public Contact

nctnprogram_rhlccc@northwestern.edu

Principal Investigator:

Shishir K. Maithel

IU Health North Hospital

Recruiting

Carmel, Indiana, United States, 46032

Contacts

Site Public Contact

317-278-5632 iutrials@iu.edu

Principal Investigator:

Anita Turk

Indiana University/Melvin and Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Site Public Contact

317-278-5632 iutrials@iu.edu

Principal Investigator:

Anita Turk

University of Kentucky/Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Contacts

Site Public Contact

859-257-3379

Principal Investigator:

Michael J. Cavnar

University of Michigan Rogel Cancer Center

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Site Public Contact

800-865-1125 CancerAnswerLine@med.umich.edu

Principal Investigator:

Benjamin D. Ferguson

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Site Public Contact

616-391-1230 crcwm-regulatory@crcwm.org

Principal Investigator:

Kathleen Y. Butler

University of Minnesota/Masonic Cancer Center

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Site Public Contact

612-624-2620

Principal Investigator:

Ajay Prakash

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Site Public Contact

855-776-0015

Principal Investigator:

Cornelius A. Thiels

Memorial Sloan Kettering Basking Ridge

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Andrea Cercek

Memorial Sloan Kettering Monmouth

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Andrea Cercek

Memorial Sloan Kettering Bergen

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Andrea Cercek

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Site Public Contact

800-767-9355 askroswell@roswellpark.org

Principal Investigator:

Anuradha Krishnamurthy

Memorial Sloan Kettering Commack

Recruiting

Commack, New York, United States, 11725

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Andrea Cercek

Memorial Sloan Kettering Westchester

Recruiting

Harrison, New York, United States, 10604

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Andrea Cercek

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Site Public Contact

212-824-7309 CCTO@mssm.edu

Principal Investigator:

James O. Park

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Andrea Cercek

Memorial Sloan Kettering Nassau

Recruiting

Uniondale, New York, United States, 11553

Contacts

Site Public Contact

212-639-7592

Principal Investigator:

Andrea Cercek

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Site Public Contact

888-275-3853

Principal Investigator:

Hope E. Uronis

Duke Cancer Center Raleigh

Recruiting

Raleigh, North Carolina, United States, 27609

Contacts

Site Public Contact

NCTNStudyTeam@dm.duke.edu

Principal Investigator:

Hope E. Uronis

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Site Public Contact

336-713-6771

Principal Investigator:

Perry Shen

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Site Public Contact

800-293-5066 Jamesline@osumc.edu

Principal Investigator:

Alex B. Blair

Saint Elizabeth Youngstown Hospital

Recruiting

Youngstown, Ohio, United States, 44501

Contacts

Site Public Contact

937-528-2900 clinical.trials@daytonncorp.org

Principal Investigator:

Howard M. Gross

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Site Public Contact

503-494-1080 trials@ohsu.edu

Principal Investigator:

Skye C. Mayo

Lehigh Valley Hospital-Cedar Crest

Recruiting

Allentown, Pennsylvania, United States, 18103

Contacts

Site Public Contact

610-402-9543 Morgan_M.Horton@lvhn.org

Principal Investigator:

Tareq Al baghdadi

Saint Vincent Hospital

Recruiting

Erie, Pennsylvania, United States, 16544

Contacts

Site Public Contact

814-452-5000

Principal Investigator:

Patrick L. Wagner

Jefferson Hospital

Recruiting

Jefferson Hills, Pennsylvania, United States, 15025

Contacts

Site Public Contact

412-359-3043 ddefazio@wpahs.org

Principal Investigator:

Patrick L. Wagner

Forbes Hospital

Recruiting

Monroeville, Pennsylvania, United States, 15146

Contacts

Site Public Contact

412-858-7746

Principal Investigator:

Patrick L. Wagner

Fox Chase Cancer Center

Recruiting

Philadelphia, Pennsylvania, United States, 19111

Contacts

Site Public Contact

215-728-4790

Principal Investigator:

Vanessa Wookey

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Site Public Contact

877-284-2000

Principal Investigator:

Patrick L. Wagner

West Penn Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Site Public Contact

412-578-5000

Principal Investigator:

Patrick L. Wagner

Wexford Health and Wellness Pavilion

Recruiting

Wexford, Pennsylvania, United States, 15090

Contacts

Site Public Contact

Dawnmarie.DeFazio@ahn.org

Principal Investigator:

Patrick L. Wagner

Vanderbilt University/Ingram Cancer Center

Recruiting

Nashville, Tennessee, United States, 37232

Contacts

Site Public Contact

800-811-8480

Principal Investigator:

Chandrasekhar Padmanabhan

Parkland Memorial Hospital

Recruiting

Dallas, Texas, United States, 75235

Contacts

Site Public Contact

214-590-5582 canceranswerline@UTSouthwestern.edu

Principal Investigator:

Adam C. Yopp

UT Southwestern Simmons Cancer Center - RedBird

Recruiting

Dallas, Texas, United States, 75237

Contacts

Site Public Contact

214-648-7097 canceranswerline@utsouthwestern.edu

Principal Investigator:

Adam C. Yopp

UT Southwestern/Simmons Cancer Center-Dallas

Recruiting

Dallas, Texas, United States, 75390

Contacts

Site Public Contact

214-648-7097 canceranswerline@UTSouthwestern.edu

Principal Investigator:

Adam C. Yopp

UT Southwestern/Simmons Cancer Center-Fort Worth

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Site Public Contact

214-648-7097 canceranswerline@UTSouthwestern.edu

Principal Investigator:

Adam C. Yopp

UT Southwestern Clinical Center at Richardson/Plano

Recruiting

Richardson, Texas, United States, 75080

Contacts

Site Public Contact

972-669-7044 Suzanne.cole@utsouthwestern.edu

Principal Investigator:

Adam C. Yopp

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Recruiting

Madison, Wisconsin, United States, 53718

Contacts

Site Public Contact

800-622-8922 clinicaltrials@cancer.wisc.edu

Principal Investigator:

Patrick Varley

University of Wisconsin Carbone Cancer Center - University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Site Public Contact

800-622-8922 clinicaltrials@cancer.wisc.edu

Principal Investigator:

Patrick Varley

More Information

Sponsor

ECOG-ACRIN Cancer Research Group

Last update posted

Aug 18, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by ECOG-ACRIN Cancer Research Group on 2026-08-18.