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Corticosteroid

HAI + Chemotherapy +/- Bevacizumab for Liver Metastases from Colorectal Cancer

Phase 2

Waitlist Available

Led By Nancy Kemeny, M.D

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

Prior chemotherapy is acceptable if last dose given ≥ 3 weeks prior to registration to this study. No chemotherapy to be given after resection of liver lesions prior to treatment on this study

History of histologically confirmed colorectal adenocarcinoma metastatic to the liver with no clinical or radiographic evidence of extrahepatic disease confirmed at MSKCC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing whether adding the drug bevacizumab to standard chemotherapy drugs may help improve survival in patients who have undergone liver surgery.

Who is the study for?

This trial is for adults over 18 with colorectal cancer that has spread to the liver, but not elsewhere. They must have had a liver resection and meet specific health criteria like normal blood counts and organ function tests. Pregnant women, those with recent serious injuries or surgeries, uncontrolled diseases like heart conditions or strokes, and known allergies to similar drugs are excluded.Check my eligibility

What is being tested?

The study aims to see if adding bevacizumab (a drug that inhibits blood vessel growth in tumors) to hepatic arterial infusion of floxuridine/dexamethasone (chemotherapy delivered directly into the liver's arteries), along with systemic chemotherapy improves disease-free survival after liver surgery.See study design

What are the potential side effects?

Bevacizumab can cause bleeding, high blood pressure, delayed wound healing, and might increase stroke risk. The chemotherapy may lead to typical side effects such as fatigue, nausea, low blood cell counts increasing infection risk, and potential liver complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I last received chemotherapy more than 3 weeks ago and haven't had any since liver surgery.

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My colorectal cancer has spread to my liver and there's no sign of it outside the liver.

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My liver cancer can potentially be fully removed by surgery, and it hasn't spread elsewhere.

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I am mostly able to care for myself.

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I am older than 18 years.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

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

To determine whether the addition of concurrent intravenous bevacizumab to HAI plus systemic chemotherapy increases the time to progression in patients with completely resected hepatic metastases from colorectal cancer

Secondary outcome measures

To assess the expression pattern of VEGFR1, VEGFR2 (angiogenesis), and VEGFR3 (lymphangiogenesis) and their cognate ligands (VEGF-A, VEGF-C, VEGF-D), and correlate with patient progression and survival following

To assess toxicity

To compare plasma levels of VEGF-A, VEGF-C, VEGF-D, and CD133+ VEGFR2+ circulating endothelial progenitors

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: 2Experimental Treatment1 Intervention

HAI plus systemic chemotherapy alone

Group II: 1Active Control1 Intervention

Bevacizumab in addition to HAI plus systemic chemotherapy

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,547 Total Patients Enrolled

Nancy Kemeny, M.DPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT00200200 — Phase 2

Colon Cancer Research Study Groups: 2, 1

Colon Cancer Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT00200200 — Phase 2

Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00200200 — Phase 2

Frequently Asked Questions

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

Has research been conducted to explore the implications of combining HAI and systemic chemotherapy treatments?

"The first HAI plus systemic chemotherapy study was conducted in 2004 by Memorial Sloan Kettering Basking Ridge (Follow Up Only). With over 1000 past studies and 355 ongoing trials, this treatment is being actively researched across the USA; particularly in Harrison, New york."

Answered by AI

In what conditions is the combination of HAI and systemic chemotherapy typically prescribed?

"HAI combined with systemic chemotherapy is primarily used to battle malignant neoplasms, but it can also be employed to treat recurrent platinum sensitive primary peritoneal cancer and advanced nonsquamous non-small cell lung cancer. Additionally, this treatment has been known to help mitigate the effects of stage iv epithelial ovarian cancer following initial surgical resection."

Answered by AI

What is the total number of participants being evaluated in this research?

"Sadly, this clinical trial has ceased searching for new patients. It was originally listed on November 19th 2004 and last edited on April 26th 2022. If you are seeking another study to participate in, presently there are 1086 trials recruiting participants with malignant neoplasm of colon and 355 studies actively enrolling those receiving HAI plus systemic chemotherapy."

Answered by AI

Is the combination of HAI and systemic chemotherapy approved by the FDA?

"We rate the safety of HAI plus systemic chemotherapy at a 2, as this is only in Phase 2 and there exists evidence to support its security yet no proof that it can be effective."

Answered by AI

Is recruitment of participants ongoing for this research study?

"Unfortunately, this clinical trial has now ceased to actively recruit patients. The original post date was November 19th 2004 and the most recent edit occurred on April 26th 2022. On the other hand, there are currently 1086 trials searching for participants suffering from malignant neoplasm of colon and 355 studies recruiting those administering HAI plus systemic chemotherapy."

Answered by AI

Are there numerous healthcare centers in North America that are currently involved with this experiment?

"At this moment in time, 5 distinct medical centres are enrolling participants for the trial. These sites can be found in Harrison and Uniondale of New york as well as other locations. Choosing a nearby site may help reduce travel requirements if you choose to participate."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combination With Chemotherapy With/Without Bevacizumab for Hepatic Metastases From Colorectal Cancer

2004. "Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combination With Chemotherapy With/Without Bevacizumab for Hepatic Metastases From Colorectal Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00200200.

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