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

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Thrombolytics, NSAIDs, others

Disqualifiers: Brain metastases, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

73 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether the addition of bevacizumab, to hepatic arterial therapy with floxuridine (FUDR) and dexamethasone (Dex) (regional chemotherapy), and either oxaliplatin or CPT-11, plus 5-fluorouracil and leucovorin (systemic chemotherapy) will increase disease free survival in patients who have undergone liver resection. The patient will be randomized (a computer generated decision as in the flip of a coin) to receive, or not to receive bevacizumab in addition to regional and systemic chemotherapy.

Research Team

Nancy Kemeny, M.D

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Abdominal and pelvic CT scans and chest CT or x-ray within 6 weeks prior to registration (MRI of abdomen may be substituted for CT of abdomen)

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

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

Exclusion Criteria

I have not had radiation to the liver, but it's okay if I had pelvic radiation over 4 weeks ago.

I do not have any serious wounds, ulcers, or unhealed bone fractures.

I take more than 325 mg of aspirin daily or use anti-inflammatory drugs that affect blood clotting.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive hepatic arterial infusion with floxuridine and dexamethasone, and systemic chemotherapy with or without bevacizumab

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• 5-fluorouracil
• Bevacizumab
• CPT-11
• Dexamethasone
• Floxuridine
• Leucovorin
• Oxaliplatin

Trial Overview 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.

Participant Groups

Group I: 2 Experimental Treatment 1 Intervention

HAI plus systemic chemotherapy alone

Group II: 1 Active Control 1 Intervention

Bevacizumab in addition to HAI plus systemic chemotherapy

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+