Active not recruitingPHASE1, PHASE2INTERVENTIONAL

D,L-MEthadone and mFOLFOX6 in Treatment of Advanced Colorectal Cancer

This research study is looking into a new way to treat advanced bowel cancer that has either stopped responding to standard treatments or couldn't be treated with them. The study combines a drug called D,L-methadone with a common chemotherapy treatment called mFOLFOX6. It's happening in two main parts: first, to find the safest and most effective dose of D,L-methadone when given with mFOLFOX6. Then, it will compare whether this combination works better at controlling the cancer after 12 weeks than mFOLFOX6 alone. Researchers will also look at how long people live, how long the cancer stays stable, their quality of life, and any side effects. The goal is to find improved treatment options for people living with this type of bowel cancer.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

AIO-Studien-gGmbH

Enrolment target

Start

17 Feb 2022

Estimated completion

01 Dec 2025

Chemo-refractory Colorectal Carcinoma

What is this study about?

This study is for people with advanced bowel cancer that hasn't responded well to other treatments. Sometimes, cancer can become 'chemo-refractory,' meaning it no longer shrinks or stops growing with regular chemotherapy. This can be very disheartening, so doctors are always looking for new ways to fight the disease.

The study combines a drug called D,L-methadone with a standard chemotherapy treatment known as mFOLFOX6. You might recognise D,L-methadone as a type of painkiller, but in this study, doctors are exploring whether it has additional effects that could help fight cancer cells when used alongside chemotherapy. The mFOLFOX6 chemotherapy is a common treatment for bowel cancer that combines several different drugs.

The study has two main steps. The first step involves a small group of people to carefully figure out the best and safest dose of D,L-methadone to give with mFOLFOX6. This is called finding the 'maximum tolerated dose.' Once this dose is confirmed, the second step will involve more patients. In this part, some patients will receive the new combination (D,L-methadone plus mFOLFOX6), while others will receive mFOLFOX6 alone. This allows the researchers to directly compare if adding D,L-methadone makes the treatment more effective at controlling the cancer, improving quality of life, or helping people live longer. They will closely monitor your health and how the treatment affects your cancer.

Key takeaways

This study is for advanced bowel cancer that hasn't responded to other treatments.
It combines a drug called D,L-methadone with standard chemotherapy.
The study aims to find the safest dose and see if the combination works better than chemotherapy alone.
You would receive regular treatments, blood tests, and scans.
Participation is voluntary, and you can withdraw at any time.
Potential benefits and risks will be fully explained by the study team.

Who may be eligible?

To be considered for this study, you would need to have advanced bowel cancer that has spread and can't be removed with surgery. Crucially, your cancer should have already been treated with most standard chemotherapy drugs (like fluoropyrimidines, oxaliplatin, irinotecan, and certain targeted therapies) and either didn't respond or got worse. You also need to have a specific type of bowel cancer called 'microsatellite stable' (MSS), which your doctor can check.

There are other important health requirements. For example, your organs like your kidneys and liver need to be working well enough, and your blood counts should be at certain levels. You shouldn't have nerve damage (neuropathy) that's worse than mild, and you must generally be fit enough to take part. You also need to not be taking certain other medications that could interfere with the study drugs. Doctors will review your full medical history to see if you meet all the criteria.

People who have a different type of bowel cancer called 'microsatellite unstable' (MSIhi) cannot join this study. You also need to be at least 18 years old, and if you have pain, it must be manageable without strong pain relief medicines called opioids. Your doctor will discuss all these points in detail with you.

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.

Do I have advanced bowel cancer that has spread?
Has my cancer already been treated with most common chemotherapy drugs and become resistant or progressed?
Do I have the 'microsatellite stable' (MSS) type of bowel cancer?
Am I generally well enough to take part, with good organ function?
Am I at least 18 years old?
Is any pain I have manageable without strong opioid painkillers?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive cycles of treatment with either the D,L-methadone plus mFOLFOX6 combination or mFOLFOX6 alone. The exact schedule will vary, but typically involves chemotherapy infusions every two weeks. You would also have regular check-ups, which include blood tests, physical examinations, and scans (like CT scans) to monitor your cancer and check for any side effects. These scans would usually happen after specific cycles of treatment to see how well it's working. You may also be asked to fill out questionnaires about your quality of life. The total duration of your participation could vary depending on how you respond to the treatment, but it would involve regular hospital visits over several months.

Potential risks and benefits

There is a chance that the new treatment combination might help control your cancer better than standard therapy, but this is not guaranteed. Potential benefits also include very close medical monitoring throughout the study. However, there are potential risks, as both D,L-methadone and mFOLFOX6 can cause side effects, including feeling tired, nausea, nerve damage, or changes in blood counts. D,L-methadone can also affect your heart or interact with other medications. The study team will explain all known side effects in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Universitätsklinikum Hamburg Eppendorf - II. Med.
Verified postcode
Hamburg, Germany
Stauferklinikum Schwäbisch Gmünd
Verified postcode
Mutlangen, Germany
Universitätsklinikum Ulm - Innere Med. I
Verified postcode
Ulm, Germany

Common questions

What is 'chemo-refractory' cancer?

It means your cancer hasn't responded well to standard chemotherapy treatments, or it has started to grow again after previous treatments.

What is D,L-methadone and how might it help?

D,L-methadone is a drug used in this study along with chemotherapy. Doctors are researching if it can make cancer cells more sensitive to chemotherapy, helping to control the cancer better.

Will I definitely get the new combined treatment?

In the second part of the study, you would be randomly assigned to either receive the new combination (D,L-methadone plus mFOLFOX6) or mFOLFOX6 chemotherapy on its own.

What kind of tests will I have during the study?

You'll have regular blood tests, physical exams, and scans like CT scans to check your health and see how your cancer is responding to treatment.

Can I stop participating in the study if I want to?

Yes, you can choose to leave the study at any time without having to give a reason, and it won't affect your future medical care.