Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

A phase I/II trial of D,L-MEthadone and mFOLFOX6 in treatment of advanced colorectal cancer (MEFOX)

This research study, called MEFOX, is looking at a new way to treat advanced bowel cancer that has spread. It combines a drug called D,L-methadone with a common chemotherapy treatment called mFOLFOX6. The study has two main parts: first, seeing what dose of D,L-methadone is safe to give alongside chemotherapy and what side effects it causes. Then, in the second part, it will compare whether adding D,L-methadone to mFOLFOX6 is better at controlling the cancer than mFOLFOX6 alone. Researchers hope to see if this combination can shrink tumours or stop them from growing for longer. This is for patients whose cancer has previously been resistant to chemotherapy.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

AIO-Studien gGmbH

Enrolment target

Start

27 Nov 2024

Patients with advanced histologically confirmed metastatic colorectal carcinoma

What is this study about?

This study is called MEFOX and it's looking into new ways to treat advanced bowel cancer (also known as colorectal cancer) that has spread to other parts of the body. When cancer has spread, it can be harder to treat, and sometimes the usual treatments don't work as well as hoped. This research is trying a new approach by combining a commonly used chemotherapy treatment called mFOLFOX6 with a drug called D,L-methadone.

The study has two main steps. In the first step (Phase I), the doctors are carefully trying out different amounts of D,L-methadone alongside the mFOLFOX6 chemotherapy. This is to find the highest dose of D,L-methadone that can be given safely without causing too many serious side effects. They'll be watching closely for any unwanted effects to make sure patients are comfortable and safe.

Once a safe dose of D,L-methadone is found, the study moves to the second step (Phase II). Here, patients will be randomly assigned to receive either the standard mFOLFOX6 chemotherapy on its own, or mFOLFOX6 combined with the chosen dose of D,L-methadone. The main aim here is to see if adding D,L-methadone makes the treatment better at controlling the cancer. This means checking if it can shrink tumours or stop them from growing for at least 12 weeks. They will also look at how patients feel, their quality of life, and how long they live, to get a full picture of the treatment's effects. This part of the study focuses on patients whose cancer hasn't responded well to previous chemotherapy.

Key takeaways

It's a study for advanced bowel cancer that has spread.
It combines standard chemotherapy with a drug called D,L-methadone.
The study has two parts: finding a safe dose, then checking if it works better.
It's for people whose cancer hasn't responded well to previous chemotherapy.
Participants will receive treatment and be closely monitored.

Who may be eligible?

To join this study, you would need to be an adult, aged 18 or over. The study is open to both men and women.

You must have advanced bowel cancer that has been confirmed by a doctor after looking at a tissue sample. This means your cancer has spread to other parts of your body and has also not responded to previous chemotherapy treatments.

Quick self-check

Are you 18 years old or older?
Do you have advanced bowel cancer that has been confirmed by a biopsy?
Has your bowel cancer spread to other parts of your body?
Has your cancer not responded to previous chemotherapy treatments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will receive treatment that includes chemotherapy (mFOLFOX6) and potentially the new drug (D,L-methadone). You will have regular hospital visits for your treatment, blood tests, and scans to check how your cancer is responding. The doctors and nurses will closely monitor you for any side effects. You will also be asked to complete questionnaires about how you are feeling and your quality of life. The total length of your participation will depend on how you respond to the treatment and the study's protocol, but the main phase of the study will assess effects for at least 12 weeks after starting treatment.

Potential risks and benefits

Potential benefits of taking part include receiving cutting-edge treatment that might be more effective than standard care, especially if your cancer hasn't responded to previous treatments. You'll also be closely monitored by a specialist medical team. However, there are potential risks, primarily from the treatments themselves. Both chemotherapy and D,L-methadone can have side effects, which the study will carefully track. These might range from common ones like sickness or tiredness to more serious but rarer effects. You will be fully informed about all known risks before deciding to join, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Germany

Common questions

What is 'advanced bowel cancer'?

This means bowel cancer that has spread from where it started to other parts of your body.

What is mFOLFOX6?

It's a common and standard combination of chemotherapy drugs used to treat bowel cancer.

What is D,L-methadone?

It's a drug being tested in this study to see if it can help improve the effectiveness of chemotherapy in treating bowel cancer.

What are 'Phase I' and 'Phase II' of a study?

Phase I is about checking if a new treatment is safe and finding the right dose. Phase II then checks if it actually works to help patients.

Will I definitely get the new drug?

In Phase I, all participants receive the new drug with chemotherapy. In Phase II, patients are randomly assigned to either receive the new drug with chemotherapy or chemotherapy alone.