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Monoclonal Antibodies
Combination Chemotherapy for Colorectal Cancer
Phase 2
Waitlist Available
Led By Christos Fountzilas, MD
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Prior treatment with a fluoropyrimidine (5-fluorouracil [5-FU] or capecitabine) and oxaliplatin in the metastatic/unresectable setting OR, recurrence within 12 months of adjuvant therapy with a regimen that included oxaliplatin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years post-treatment
Awards & highlights
Study Summary
This trial is testing a new combination of drugs to treat patients with colorectal cancer that has spread or can't be removed by surgery. The drugs work in different ways to stop the growth of tumor cells. The new combination may work better than traditional chemotherapy and bevacizumab.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, diarrhea from the chemotherapy drugs TAS-102 and irinotecan; high blood pressure and increased risk of bleeding from bevacizumab; as well as potential allergic reactions to any of the medications used.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I've been treated with specific chemotherapy drugs for my advanced cancer or it came back within a year after treatment.
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My colorectal cancer cannot be removed by surgery and has spread.
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My kidney function, measured by creatinine levels, is within the normal range.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years post-treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years post-treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Median progression free survival (PFS)
Secondary outcome measures
Aggregate rates of adverse events
Disease-specific survival (DSS)
Median overall survival (OS)
+1 moreTrial Design
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Irinotecan
2017
Completed Phase 4
~2680
Bevacizumab
2013
Completed Phase 4
~5280
Trifluridine and Tipiracil Hydrochloride
2019
Completed Phase 2
~70
Find a Location
Who is running the clinical trial?
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,816 Total Patients Enrolled
National Comprehensive Cancer NetworkNETWORK
115 Previous Clinical Trials
7,593 Total Patients Enrolled
Christos Fountzilas, MDPrincipal InvestigatorRoswell Park Cancer Institute
2 Previous Clinical Trials
45 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have severe heart problems like unstable chest pain, heart failure needing treatment, or serious irregular heartbeat.I am fully active or can carry out light work.I haven't had a different cancer, except for some skin or cervical types, in the last 3 years.I haven't had any blood clots in the last 3 months, or if I have, they're under control with medication.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.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 haven't had a stroke or heart attack in the last 6 months.My kidney function, measured by creatinine levels, is within the normal range.I am currently pregnant or breastfeeding.I have no major side effects from past treatments, except for hair loss or mild nerve issues.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.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (irinotecan, bevacizumab, TAS-102)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How is Trifluridine and Tipiracil Hydrochloride typically employed?
"Trifluridine and Tipiracil Hydrochloride is most commonly used for the prevention of vaccinia infection in the cornea and conjunctiva. It can also be taken to treat multiple other conditions including recurrent platinum-sensitive epithelial ovarian cancer, ras wild-type with previous of anti-egfr therapy, and malignant neoplasms."
Answered by AI
Are Trifluridine and Tipiracil Hydrochloride dangerous for human beings?
"Even though there is no data supporting trifluridine and tipiracil hydrochloride's efficacy, there is enough evidence backing its safety to warrant a score of 2."
Answered by AI
What other research has been done on the effects of Trifluridine and Tipiracil Hydrochloride?
"As of now, there are a total of 640 ongoing clinical trials studying Trifluridine and Tipiracil Hydrochloride. Out of those, 143 are in Phase 3. However, the majority of these studies are based in Adelaide, South Australia. In total, there are 25955 locations running studies for this treatment."
Answered by AI
Are there any available slots for volunteers in this experiment?
"The data on clinicaltrials.gov does appear to show that this particular trial is still recruiting patients. The listing was first created on December 27th, 2019 and was last updated on June 22nd, 2022. They are looking for a total of 42 individuals across 1 location."
Answered by AI
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