Combination Chemotherapy for Colorectal Cancer
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have had anti-cancer therapy within 2 weeks before starting the study medication. It's best to discuss your current medications with the trial team.
Is the combination chemotherapy of TAS-102 and Bevacizumab safe for humans?
The combination of TAS-102 (trifluridine/tipiracil) and Bevacizumab has been studied for safety in patients with metastatic colorectal cancer. Common side effects include nausea and vomiting, and some patients may experience blood-related issues like neutropenia (low white blood cell count). However, with dose adjustments, this treatment is generally considered safe for use in humans.12345
What makes the drug combination of Bevacizumab, Irinotecan, and TAS-102 unique for treating colorectal cancer?
This drug combination is unique because it combines TAS-102, a chemotherapy drug, with bevacizumab, which helps prevent the growth of blood vessels that feed tumors, offering a treatment option for patients who have not responded to standard therapies. It has shown to improve survival in patients with metastatic colorectal cancer, especially when other treatments have failed.13567
What data supports the effectiveness of the drug combination of TAS-102 and bevacizumab for colorectal cancer?
Research shows that the combination of TAS-102 (trifluridine and tipiracil) and bevacizumab can improve survival in patients with metastatic colorectal cancer, especially those who have already tried other treatments. Studies have found that this combination can help patients live longer and delay the progression of the disease.13589
Who Is on the Research Team?
Christos Fountzilas, MD, FACP
Principal Investigator
Roswell Park Cancer Institute
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive irinotecan IV over 90 minutes and bevacizumab IV over 30-90 minutes on days 1 and 15, and trifluridine and tipiracil hydrochloride orally twice daily on days 2-6 and 16-20. Cycles repeat every 28 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then every 6 months for up to 2 years.
What Are the Treatments Tested in This Trial?
Interventions
- Bevacizumab
- Irinotecan
- TAS-102
Bevacizumab is already approved in European Union, United States, Japan, Canada for the following indications:
- Colorectal cancer
- Breast cancer
- Non-small cell lung cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Glioblastoma
- Renal cell carcinoma
- Cervical cancer
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
- Colorectal cancer
- Non-small cell lung cancer
- Breast cancer
- Renal cell carcinoma
- Ovarian cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Roswell Park Cancer Institute
Lead Sponsor
National Comprehensive Cancer Network
Collaborator