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Corticosteroid

Chemotherapy + Hepatic Arterial Infusion for Colorectal Cancer

Phase 2
Waitlist Available
Led By Michael D'Angelica, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No clinical or radiographic evidence of extrahepatic disease
If present, the primary tumor will be resected at the time of pump placement
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is studying a treatment for colorectal cancer that has spread to the liver. The treatment is a combination of chemotherapy drugs and two other drugs, given directly into the arteries around the tumor.

Who is the study for?
This trial is for patients with colorectal cancer that has spread to the liver, who may have had prior chemotherapy but no hepatic arterial infusion or certain other treatments. They should not have widespread disease outside the liver, significant blood or heart conditions, active infections, or be pregnant. Adequate organ function and a good performance status are required.Check my eligibility
What is being tested?
The study tests hepatic arterial infusion of floxuridine and dexamethasone combined with systemic chemotherapy drugs (fluorouracil, oxaliplatin, leucovorin calcium, irinotecan hydrochloride) in treating liver metastases from colorectal cancer. The goal is to see if this approach kills more tumor cells than standard treatment.See study design
What are the potential side effects?
Potential side effects include reactions at the infusion site in the liver, general chemotherapy-related issues like nausea and fatigue, increased risk of infection due to lowered white blood cell counts, bleeding complications from low platelets count and possible damage to organs such as kidneys or liver.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has not spread outside my liver.
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My primary tumor will be removed when my pump is placed.
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My liver cancer cannot be removed by surgery, as confirmed by specialists.
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My colorectal cancer has spread to my liver.
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I can care for myself but may not be able to do active work.
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I do not have any current infections.
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My liver cancer cannot be removed by surgery.
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I do not have any bleeding disorders.
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Less than 70% of my liver is affected by cancer.
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I am fit for major liver surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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
Resectability rate
Secondary outcome measures
Antitumor activity
Median time to progression
Response rate
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Group 2Experimental Treatment5 Interventions
Patients receive HAI therapy as in group 1. Patients also receive irinotecan hydrochloride IV over 30 minutes and leucovorin calcium IV over 30 minutes on days 1 and 15 and fluorouracil IV continuously over 48 hours on days 1, 2, 15, and 16. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Group 1Experimental Treatment4 Interventions
Patients receive hepatic arterial infusion (HAI) therapy comprising floxuridine and dexamethasone continuously on days 1-14. Patients also receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 30 minutes on days 1 and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
fluorouracil
1994
Completed Phase 3
~8440
floxuridine
2003
Completed Phase 3
~370
dexamethasone
1995
Completed Phase 3
~9860
oxaliplatin
2002
Completed Phase 3
~6370
leucovorin calcium
1999
Completed Phase 3
~8620
irinotecan hydrochloride
1999
Completed Phase 3
~3030

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,556 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,089 Total Patients Enrolled
Michael D'Angelica, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
4 Previous Clinical Trials
1,622 Total Patients Enrolled

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT00492999 — Phase 2
Colorectal Cancer Research Study Groups: Group 2, Group 1
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00492999 — Phase 2

Frequently Asked Questions

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

What are the long-term effects of oxaliplatin treatment?

"While there is some data supporting oxaliplatin's safety, it only received a score of 2 because this is a phase 2 trial and thus there is no clinical evidence yet of the medication's efficacy."

Answered by AI

Are individuals over the age of 30 able to participate in this clinical trial?

"This study's inclusion criteria allows for patients aged 18-120 to enroll. There are 183 clinical trials that focus on people under the age of 18 and 2360 for patients over 65."

Answered by AI

Are there any patients still being accepted into this program?

"Unfortunately, this clinical trial is not presently open to recruitment. Although, it was updated as recently as February 4th, 2022. There are 1266 other trials actively recruiting patients with colorectal cancer and 1226 for oxaliplatin if you wish to look into other options."

Answered by AI

If a patient were interested in enrolling in this clinical trial, how many different hospitals would they have to choose from?

"To make the study more accessible to a larger number of people, it is being run from 5 different locations. They are based in Rockville Centre, Commack and Basking Ridge as well as 2 other undisclosed locations. If you do decide to participate in the trial, please select the site that is most convenient for you to attend in order to minimize travel time and hassle."

Answered by AI

Are there other examples of research using oxaliplatin?

"As of right now, 1226 studies are using oxaliplatin. 345 of those ongoing investigations are in Phase 3. Even though a large number of these experiments are based in Guangzhou, Guangdong, there 44731 total locations running trials for this medication."

Answered by AI

What is the limit to how many people can join this clinical trial?

"Unfortunately, this clinical trial is no longer looking for participants. The listing was created on May 1st 2007 and edited February 4th 2022. However, there are still many other trials seeking patients with colorectal cancer (1266 active listings) or oxaliplatin (1226 active listings)."

Answered by AI

Who meets the ideal candidate criteria for enrolling in this research project?

"This study is enrolling 64 patients with colorectal cancer aged 18 and 120. Most importantly, candidates should meet the following criteria: Must have inoperable liver metastases confirmed by 2-3 hepatobiliary surgeons and the assigned radiologist, Previously treated or untreated disease, Primary tumor may be present at study registration provided it is not obstructing the intestinal lumen or is significantly bleeding, When a margin-negative resection would require resection of all three hepatic veins, both portal veins, or the retrohepatic vena cava, Liver metastases < 70% of the liver parenchyma"

Answered by AI

What are the most popular indications for oxaliplatin?

"Oxaliplatin is commonly used to stop the spread of cancer and treat other conditions such as ophthalmia, sympathetic, branch retinal vein occlusion, small cell lung cancer (sclc)."

Answered by AI
Recent research and studies
~0 spots leftby May 2024