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RECRUITING Phase 3 ClinicalTrials.gov

Testing 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 • ClinicalTrials.gov ID: NCT05863195

Registry updated: 2026-09-24
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Description

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.

Interventions

  • Bevacizumab (Biological)
    Given IV
  • Capecitabine (Drug)
    Given PO
  • Cetuximab (Biological)
    Given IV
  • Computed Tomography (Procedure)
    Undergo SPECT/CT and/or CT
  • Floxuridine (Drug)
    Given via HAI pump
  • Fluorouracil (Drug)
    Given IV
  • Implantation (Procedure)
    Undergo surgery to place the HAI pump
  • Intrahepatic Infusion Procedure (Procedure)
    Undergo HAI
  • Irinotecan (Drug)
    Given IV
  • Leucovorin (Drug)
    Given IV
  • Magnetic Resonance Imaging (Procedure)
    Undergo MRI
  • Oxaliplatin (Drug)
    Given IV
  • Panitumumab (Biological)
    Given IV
  • Single Photon Emission Computed Tomography (Procedure)
    Undergo SPECT/CT

Eligibility criteria

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 previous first-line chemotherapy that meets 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 measurable disease * Patients who have disease progression, in the judgement of the treating multidisciplinary team, are not eligible. * This requirement does not apply to patients who developed new colorectal liver metastases within 12 months of completing adjuvant systemic therapy for stage II-III colorectal cancer * 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. * NOTE: Patients who are deemed technically resectable but simultaneous biologically unresectable are not eligible. * Patient must undergo multiphase imaging of the chest, abdomen, and pelvis inclusive of CT and/or MRI angiography to confirm acceptable hepatic arterial anatomy for HAI and to rule out extrahepatic disease within 28 days prior to randomization. * NOTE: If the patient had remote liver-arterial phase imaging greater than 4 weeks from randomization, then only a single phase (portal venous) intravenous contrasted staging CT and/or MRI of the chest/abdomen/pelvis is required. * 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. * 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 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. * Leukocytes \>= 3,000/mcL (obtained =\< 28 days prior to protocol randomization) * Absolute neutrophil count (ANC) \>= 1,500/mcL (obtained =\< 28 days prior to protocol randomization) * Platelets \>= 100,000/mcL (obtained =\< 28 days prior to protocol randomization) * Total Bilirubin =\< 1.5 mg/dL (obtained =\< 28 days prior to protocol randomization) * Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) =\< 3.0 x institutional upper limit of normal (ULN) (obtained =\< 28 days prior to protocol randomization) * Creatinine =\< 1.5 x institutional ULN OR creatinine clearance \>= 50 mL/min calculated by the Cockcroft-Gault method (obtained =\< 28 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

Conditions

Metastatic Colorectal Carcinoma Metastatic Malignant Neoplasm in the Liver Stage IV Colorectal Cancer AJCC v8 Unresectable Colorectal Carcinoma

Locations

  • University of Alabama at Birmingham Cancer Center — Birmingham, Alabama, United States
  • Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
  • Banner-University Medical Center Phoenix — Phoenix, Arizona, United States
  • Banner Boswell Medical Center — Sun City, Arizona, United States
  • UCHealth University of Colorado Hospital — Aurora, Colorado, United States
  • UM Sylvester Comprehensive Cancer Center at Aventura — Aventura, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Hollywood — Hollywood, Florida, United States
  • University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Kendall — Miami, Florida, United States
  • UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida, United States
  • Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
  • Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
  • Northwestern University — Chicago, Illinois, United States
  • University of Chicago Comprehensive Cancer Center — Chicago, Illinois, United States
  • Northwestern Medicine Cancer Center Old Irving Park — Chicago, Illinois, United States
  • Memorial Hospital East — Shiloh, Illinois, United States
  • IU Health North Hospital — Carmel, Indiana, United States
  • Indiana University/Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
  • University of Kentucky/Markey Cancer Center — Lexington, Kentucky, United States
  • University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States
  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital — Grand Rapids, Michigan, United States
  • University of Minnesota/Masonic Cancer Center — Minneapolis, Minnesota, United States
  • Mayo Clinic in Rochester — Rochester, Minnesota, United States
  • Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri, United States
  • Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri, United States
  • Washington University School of Medicine — St Louis, Missouri, United States
  • Siteman Cancer Center-South County — St Louis, Missouri, United States
  • Siteman Cancer Center at Christian Hospital — St Louis, Missouri, United States
  • Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
  • Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
  • Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
  • Roswell Park Cancer Institute — Buffalo, New York, United States
  • Memorial Sloan Kettering Commack — Commack, New York, United States
  • Memorial Sloan Kettering Westchester — East White Plains, New York, United States
  • Mount Sinai Hospital — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center — New York, New York, United States
  • Memorial Sloan Kettering Nassau — Uniondale, New York, United States
  • Duke University Medical Center — Durham, North Carolina, United States
  • Duke Cancer Center Raleigh — Raleigh, North Carolina, United States
  • Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
  • Case Western Reserve University — Cleveland, Ohio, United States
  • Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
  • Saint Elizabeth Youngstown Hospital — Youngstown, Ohio, United States
  • Oregon Health and Science University — Portland, Oregon, United States
  • Lehigh Valley Hospital-Cedar Crest — Allentown, Pennsylvania, United States
  • Saint Vincent Hospital — Erie, Pennsylvania, United States
  • Jefferson Hospital — Jefferson Hills, Pennsylvania, United States
  • Forbes Hospital — Monroeville, Pennsylvania, United States
  • Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
  • Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
  • West Penn Hospital — Pittsburgh, Pennsylvania, United States
  • Wexford Health and Wellness Pavilion — Wexford, Pennsylvania, United States
  • Vanderbilt University/Ingram Cancer Center — Nashville, Tennessee, United States
  • Parkland Memorial Hospital — Dallas, Texas, United States
  • UT Southwestern Simmons Cancer Center - RedBird — Dallas, Texas, United States
  • UT Southwestern/Simmons Cancer Center-Dallas — Dallas, Texas, United States
  • UT Southwestern/Simmons Cancer Center-Fort Worth — Fort Worth, Texas, United States
  • UT Southwestern Clinical Center at Richardson/Plano — Richardson, Texas, United States
  • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center — Madison, Wisconsin, United States
  • University of Wisconsin Carbone Cancer Center - University Hospital — Madison, Wisconsin, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record