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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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Cetuximab

2011

Completed Phase 3

~2480

Computed Tomography

2017

Completed Phase 2

~2790