Chemotherapy + Hepatic Arterial Infusion for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new method to treat colorectal cancer that has spread to the liver. The approach combines chemotherapy with hepatic arterial infusion, a technique that delivers cancer-fighting drugs directly to the liver. Researchers are investigating whether this combination is more effective at killing cancer cells. Ideal participants have colorectal cancer that has specifically spread to the liver and cannot be surgically removed. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications, but you cannot take high doses of aspirin or certain anti-inflammatory drugs. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that patients have tolerated hepatic arterial infusion (HAI) with floxuridine and dexamethasone, along with chemotherapy drugs like oxaliplatin and irinotecan, quite well. Specifically, some studies showed that 44% of patients with liver cancer spread from colorectal cancer responded positively, indicating effectiveness for some individuals. In terms of safety, these drug combinations have been used before, and while side effects exist, many patients manage them well.
For the other treatment group using HAI with irinotecan, leucovorin, and fluorouracil, research also indicates safety and effectiveness for treating liver cancer spread. Past data suggests these drugs can help when other treatments fail. Side effects can occur, but many patients find them tolerable.
Overall, both treatment groups in the trial use drugs previously tested, with safety records suggesting they are generally well-tolerated, though individual experiences may vary.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for colorectal cancer, which often rely on systemic chemotherapy, the treatments under study use hepatic arterial infusion (HAI) to deliver chemotherapy directly to the liver. This method allows for higher concentrations of drugs like floxuridine and dexamethasone to be targeted to liver tumors with potentially fewer systemic side effects. Additionally, the combination of drugs such as irinotecan hydrochloride and oxaliplatin with HAI offers a unique approach that could enhance effectiveness against liver metastases. Researchers are excited about this treatment because it represents a novel approach that could improve outcomes for patients with colorectal cancer that has spread to the liver.
What evidence suggests that this trial's treatments could be effective for colorectal cancer that has spread to the liver?
Research has shown that delivering cancer-fighting drugs directly to the liver through hepatic arterial infusion (HAI) can effectively treat colorectal cancer that has spread to the liver. In this trial, one group of participants will receive HAI therapy with floxuridine and dexamethasone, along with chemotherapy drugs such as oxaliplatin and irinotecan. Some studies have found that using HAI with these drugs can be done safely and may improve outcomes for patients with liver tumors.
Another group in this trial will receive HAI with a combination of irinotecan, leucovorin, and fluorouracil. Research has found that this approach can sometimes lead to a complete response, meaning all signs of cancer disappear, although this is rare. These treatments deliver the drugs directly to the liver, which can help stop tumor growth more effectively.678910Who Is on the Research Team?
Michael D'Angelica, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Nancy E. Kemeny, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive hepatic arterial infusion therapy with floxuridine and dexamethasone, combined with systemic chemotherapy. Courses repeat every 4 weeks.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs every 3 months for 2 years, every 4 months for 3 years, and then annually.
What Are the Treatments Tested in This Trial?
Interventions
- Dexamethasone
- Floxuridine
- Fluorouracil
- Hepatic Arterial Infusion
- Irinotecan Hydrochloride
- Leucovorin Calcium
- Oxaliplatin
Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Immune system disorders
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
- Neoplastic diseases
- Nervous system disorders
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator