Combination Chemotherapy for Colorectal Cancer

Palo Alto (17 mi)

Christos Fountzilas MD, FACP | Roswell ...

Overseen byChristos Fountzilas, MD, FACP

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Roswell Park Cancer Institute

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This trial tests a combination of three drugs to treat advanced colorectal cancer. It targets patients whose cancer has spread or cannot be surgically removed. The drugs work together to kill cancer cells, block their growth, and help the immune system fight the cancer. Oxaliplatin is a new drug that has been recently added to initial treatments for advanced colorectal cancer.

Eligibility Criteria

This trial is for adults with advanced colorectal cancer that has spread or can't be surgically removed. Participants must have had prior treatment with certain chemotherapy drugs, have good physical function (ECOG 0-1), and meet specific blood count and organ function criteria. Pregnant women, those with recent major surgery, uncontrolled high blood pressure, serious heart conditions, or untreated brain metastases cannot join.

Inclusion Criteria

I am fully active or can carry out light work.

I've been treated with specific chemotherapy drugs for my advanced cancer or it came back within a year after treatment.

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

My kidney function, measured by creatinine levels, is within the normal range.

Exclusion Criteria

I have previously been treated with TAS-102 or irinotecan.

I haven't had cancer treatment in the last 2 weeks.

I have brain metastases that have not been treated.

I have Gilbert's syndrome.

I am currently pregnant or breastfeeding.

I have not had severe bleeding in the last 4 weeks.

I have not had major surgery in the last 4 weeks.

I have an infection that could make treatment risky.

Treatment Details

The study tests a combination of TAS-102 (a chemotherapy drug), irinotecan (another chemo drug), and bevacizumab (an immunotherapy agent) in patients who've previously been treated for metastatic or unresectable colorectal cancer. The goal is to see if this combo is more effective than traditional treatments.

1Treatment groups

Experimental Treatment

Group I: Treatment (irinotecan, bevacizumab, TAS-102)Experimental Treatment3 Interventions

Patients receive irinotecan IV over 90 minutes and bevacizumab IV over 10 minutes on days 1 and 15. Patients also receive trifluridine and tipiracil hydrochloride PO BID on days 2-6 and 16-20. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

🇪🇺 Approved in European Union as Avastin for: