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Chemotherapy

Pump Chemotherapy for Colorectal Cancer

Phase 3
Recruiting
Led By Michael Lidsky
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient must meet technical unresectability criteria
Patient must be >= 18 years of age
Must not have
Patient must not have CRLM that could be resected with 2-stage hepatectomy
Patient must not have a liver tumor burden exceeding 70% of total liver volume
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

"This trial is comparing using a special pump to deliver chemotherapy directly to the liver along with regular chemotherapy versus regular chemotherapy alone for patients with colorectal cancer that has spread to the liver and cannot be removed by

Who is the study for?
Adults with colorectal cancer that has spread to the liver and can't be surgically removed may join. They should have stable or no extra liver disease, possibly small lung nodules, and must have had 3-6 months of initial chemotherapy with certain drugs. Those who've had new liver metastases within a year after adjuvant therapy for stage II-III colorectal cancer are also eligible.
What is being tested?
The PUMP trial is testing if adding pump chemotherapy (HAI) directly into the liver using floxuridine improves outcomes compared to standard chemotherapy alone in patients with unresectable colorectal liver metastases. The study will compare tumor shrinkage and stability between both treatments.
What are the potential side effects?
Possible side effects include reactions at the catheter site, increased risk of infections due to lowered white blood cells, fatigue from anemia, bleeding issues from low platelets, nerve damage causing numbness or tingling sensations (neuropathy), diarrhea, mouth sores, skin reactions like rash or dry skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer cannot be removed with surgery.
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I am 18 years old or older.
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My cancer has not spread outside my liver.
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My colorectal cancer has spread to my liver and cannot be removed by surgery.
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My cancer is not getting worse after my first chemotherapy.
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I am very active and fit for surgery.
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I am HIV-positive, on treatment, and my viral load is undetectable.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My liver metastases cannot be removed with a two-stage surgery.
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My liver tumor does not take up more than 70% of my liver.
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I have never been treated with HAI/floxuridine.
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My colorectal cancer is not MSI-H.
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I have never had radiation therapy to my liver.
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I have not had any prior artery-blocking cancer treatments.
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I do not have cirrhosis or signs of high blood pressure in the liver.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall survival (OS)
Secondary study objectives
Extrahepatic-PFS
Hepatic PFS
Incidence of adverse events
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (HAI, floxuridine, standard chemotherapy)Experimental Treatment11 Interventions
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.
Group II: Arm B (standard chemotherapy)Active Control8 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin
2005
Completed Phase 4
~6010
Floxuridine
2012
Completed Phase 2
~180
Cetuximab
2011
Completed Phase 3
~2480
Single Photon Emission Computed Tomography
2008
Completed Phase 4
~310
Implantation
2016
Completed Phase 4
~240
Fluorouracil
2014
Completed Phase 3
~11700
Panitumumab
2017
Completed Phase 3
~7150
Oxaliplatin
2011
Completed Phase 4
~2890
Computed Tomography
2017
Completed Phase 2
~2740
Irinotecan
2017
Completed Phase 3
~2580

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor
119 Previous Clinical Trials
178,639 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,592 Total Patients Enrolled
Michael LidskyPrincipal InvestigatorECOG-ACRIN Cancer Research Group
~272 spots leftby Jun 2029
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