Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Evaluation of the Efficacy and the Safety of FOLFIRINOX3 Bevacizumab Treatment in Patients With Colorectal Cancer (FOLFIRINOX 3)

This research trial is testing a new way to give a treatment called FOLFIRINOX with bevacizumab for advanced bowel cancer. This particular type of bowel cancer has already been treated with other chemotherapy drugs like oxaliplatin and irinotecan, but the cancer has continued to grow. The main idea is to see if giving one of the chemotherapy drugs, irinotecan, at different times during the treatment cycle makes it work better. Normally, irinotecan is given all at once. In this trial, it will be given at the beginning and end of each treatment cycle. Doctors hope this change could lead to a better response to treatment for patients. The study will also carefully check for any side effects and how safe this new approach is.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Centre Georges Francois Leclerc

Enrolment target

Start

07 Nov 2018

Estimated completion

16 Jul 2025

Colorectal Cancer

What is this study about?

This research study, called FOLFIRINOX 3, is looking for a new and potentially more effective way to treat advanced bowel cancer (metastatic colorectal cancer). This is for patients whose cancer has continued to grow despite having already received standard chemotherapy treatments that included oxaliplatin and irinotecan.

The treatment being investigated is a combination of several chemotherapy drugs (5-fluorouracil, oxaliplatin, folinic acid) along with a targeted drug called bevacizumab, and irinotecan. What's different in this trial is how irinotecan is given. Normally, irinotecan is given once during each treatment cycle. In this study, the doctors are exploring whether splitting the dose of irinotecan – giving some at the start and some at the end of each treatment cycle – could make the entire treatment work better against the cancer. The hope is that this new way of giving the drug might increase the chances of the cancer shrinking or responding more effectively to the treatment.

The study has two main parts. The first part (Phase 1) will be focused on carefully checking the safety of this new treatment approach and making sure the side effects are manageable. Once the safety is confirmed, the second part (Phase 2) will then look at how well the new treatment works in shrinking the cancer or stopping it from growing. Researchers will compare the results of this new approach with what they would expect from the current standard treatment. They will also look at other important things like how long patients live, how long they stay free from cancer progression, and their general quality of life during and after treatment.

Key takeaways

This study is for advanced bowel cancer where previous treatments haven't worked.
It tests a new timing for a chemotherapy drug called irinotecan.
The goal is to improve treatment effectiveness and monitor safety.
Participation involves regular hospital visits, blood tests, and scans.
You can stop participating at any time.

Who may be eligible?

To join this study, you would generally need to be an adult (18 years or older) diagnosed with bowel cancer that has spread to other parts of the body. You should have already received specific chemotherapy treatments like oxaliplatin and irinotecan, as well as certain anti-angiogenic drugs (like bevacizumab or aflibercept). Your overall health should be good enough to receive this type of treatment, as measured by a doctor, and you should not have other serious illnesses.

There are also some specific medical requirements, including normal organ function (like your liver, kidneys, and blood cells) as shown by recent blood tests. You must also have at least one part of your cancer that can be measured on a scan, so doctors can track whether the treatment is working. Women who could become pregnant must use effective birth control and have a negative pregnancy test before starting the study.

You would not be able to join if you have had another cancer in the past five years (apart from certain very early skin or cervical cancers), or if your cancer has spread to your brain. Other reasons for not being able to join include if doctors believe your life expectancy is very short (under 3 months), or if you have certain medical conditions that would make bevacizumab treatment unsafe, such as recent major surgery, a high risk of blood clots, or bleeding issues. You also need to be able to follow all the study instructions and attend regular appointments.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years or older?
Do you have bowel cancer that has spread?
Have you already had chemotherapy including oxaliplatin and irinotecan?
Is your general health good enough for more treatment?
Do you have a measurable area of cancer on scans?
If you are a woman who could become pregnant, are you using effective birth control?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the FOLFIRINOX Bevacizumab treatment, but with a different timing for one of the drugs (irinotecan). This means you would have regular chemotherapy cycles, where the irinotecan would be given at the start and end of each cycle. You would have regular visits to the hospital for your treatment sessions and for check-ups with the study doctors and nurses.

During these visits, you would have blood tests to monitor your health and check for side effects. You would also have regular scans (like CT scans of your chest, abdomen, and pelvis) to see how the treatment is affecting your cancer. Your quality of life will also be assessed, which might involve filling out questionnaires. The doctors and nurses will continuously monitor you for any side effects and overall well-being throughout the treatment period. The total duration of your participation would depend on how your cancer responds to the treatment and your tolerance to any side effects.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment approach that might be more effective than current standard options for your specific type of bowel cancer. However, there are also potential risks, including side effects from the chemotherapy and other drugs. These side effects can vary from person to person and will be closely monitored by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Centre Georges François Leclerc
Verified postcode
Dijon, France

Common questions

What is FOLFIRINOX Bevacizumab?

It's a combination of several powerful chemotherapy and targeted drugs commonly used to treat advanced bowel cancer.

What makes this study different from standard treatment?

The study is trying a new way of giving one of the chemotherapy drugs, irinotecan, in two smaller doses during each treatment cycle instead of one large dose, to see if it works better.

What is the main goal of this study?

The main goal is to find out if this new way of giving irinotecan makes the treatment more effective at shrinking bowel cancer and is safe to use.

Will I get to choose which treatment I receive?

No, this study is testing a specific new approach to the FOLFIRINOX Bevacizumab treatment. All participants will receive the treatment with the modified irinotecan schedule.

What does 'metastatic colorectal cancer' mean?

It means bowel cancer that has spread from its original location to other parts of the body.