← Back to Search

Chemotherapy

Arm A (HAI, floxuridine, standard 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

My cancer cannot be removed with surgery.

Select...

I am 18 years old or older.

Select...

My cancer has not spread outside my liver.

Select...

My colorectal cancer has spread to my liver and cannot be removed by surgery.

Select...

My cancer is not getting worse after my first chemotherapy.

Select...

I am very active and fit for surgery.

Select...

I am HIV-positive, on treatment, and my viral load is undetectable.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall survival (OS)

Secondary outcome measures

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

Floxuridine

2012

Completed Phase 2

~180

Oxaliplatin

2011

Completed Phase 4

~2560

Cetuximab

2011

Completed Phase 3

~2480

Computed Tomography

2017

Completed Phase 2

~2720

Implantation

2016

Completed Phase 4

~240

Fluorouracil

2014

Completed Phase 3

~11540

Irinotecan

2017

Completed Phase 4

~2680

Leucovorin

2005

Completed Phase 4

~5730

Panitumumab

2020

Completed Phase 3

~7130

Single Photon Emission Computed Tomography

2008

Completed Phase 4

~310

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

ECOG-ACRIN Cancer Research GroupLead Sponsor

116 Previous Clinical Trials

176,514 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,695 Previous Clinical Trials

40,929,379 Total Patients Enrolled

Michael LidskyPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals actively participating in this clinical study?

"A total of 408 eligible subjects are required to enroll in this research study. Eligible participants have the option to join from various locations, such as Memorial Hospital East located in Shiloh, Illinois, and Duke University Medical Center situated in Durham, North carolina."

Answered by AI

At present, how many distinct locations are simultaneously conducting this experimental investigation?

"At present, this clinical trial is enrolling participants from 18 diverse sites, including but not limited to Shiloh, Durham, and Aurora. Opting for a site in close proximity can alleviate travel burdens when joining the study."

Answered by AI

Are there ongoing efforts to actively enroll participants in this trial?

"Yes, the details on clinicaltrials.gov affirm that this study is presently enrolling participants. Originally shared on October 19th, 2023 and last revised on April 18th, 2024, this trial aims to enroll a total of 408 individuals across eighteen different sites."

Answered by AI

Is Arm A (HAI, floxuridine, standard chemotherapy) considered a safe treatment option for patients?

"According to our assessment at Power, Arm A (HAI, floxuridine, standard chemotherapy) has been rated a 3 for safety. This rating reflects the Phase 3 trial stage and is based on existing efficacy data as well as extensive safety data from previous rounds of testing."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05863195.

All > Colorectal Cancer Chicago