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Study on Methadone Hydrochloride and Drug Combination for Patients with Advanced Metastatic Colorectal Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of advanced colorectal cancer, which is a type of cancer that affects the colon or rectum and has spread to other parts of the body. The study will explore the effects of combining a medication called D,L-methadone with a chemotherapy regimen known as mFOLFOX6. The mFOLFOX6 regimen includes a combination of drugs: fluorouracil, oxaliplatin, and folinic acid. The purpose of the study is to evaluate how well this combination works in controlling the disease compared to using mFOLFOX6 alone.

Participants in the study will receive either the combination of D,L-methadone and mFOLFOX6 or mFOLFOX6 alone. The study will be conducted in two phases. The first phase will focus on understanding the safety and appropriate dosage of D,L-methadone when used with mFOLFOX6. The second phase will assess the effectiveness of the combination in controlling the cancer. Some participants may receive a placebo instead of D,L-methadone to compare the outcomes. The study will monitor the response of the cancer to the treatment over a period of 12 weeks.

The trial aims to provide insights into whether adding D,L-methadone to the standard mFOLFOX6 treatment can improve outcomes for patients with advanced colorectal cancer. The study will also look at the overall survival, quality of life, and safety of the treatment. Additionally, researchers will examine the expression of a specific protein called the μ opioid receptor in tumor tissue to see if it affects the treatment's effectiveness. The study is expected to continue until October 2027.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will be informed about the study's purpose, procedures, and potential risks and benefits. You will be required to sign an informed consent form, which confirms your understanding and willingness to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history and conducting necessary tests to ensure you meet the trial's criteria.

  3. Step 3

    Treatment phase I

    In phase I, you will receive a combination of medications to evaluate their safety and determine the appropriate dosage. The medications include methadone hydrochloride taken orally, and folinic acid, fluorouracil, and oxaliplatin administered intravenously.

    The goal is to assess the toxicity and establish the maximum tolerated dose of methadone hydrochloride when combined with the other medications.

  4. Step 4

    Treatment phase II

    In phase II, the focus is on evaluating the effectiveness of the treatment. You will continue to receive the combination of medications, and the response of your condition will be monitored over a period of 12 weeks.

    The aim is to compare the effect of the combination treatment with the standard treatment on controlling the disease.

  5. Step 5

    Regular monitoring

    Throughout the trial, regular monitoring will be conducted to assess your health and the treatment's impact. This includes routine blood tests, imaging studies, and other necessary evaluations.

    Your safety and well-being will be closely observed, and any side effects or changes in your condition will be addressed promptly.

  6. Step 6

    End of trial

    At the end of the trial, a final assessment will be conducted to evaluate the overall outcomes of the treatment. You will be informed about the results and any further steps or follow-up care that may be necessary.

Who can join the trial?

16 criteria

  • Patients must have advanced metastatic colorectal cancer that cannot be removed by surgery and does not respond to chemotherapy.
  • The cancer must be a microsatellite stable subset (MSS) of colorectal cancer.
  • Patients must have tried chemotherapy or radiochemotherapy up to two weeks before starting the study medication. For the second phase of the trial, this treatment must have failed.
  • There must be a break of at least 6 months from using oxaliplatin, a chemotherapy drug, before starting the study medication.
  • Patients should not have polyneuropathy (nerve damage) worse than grade 1.
  • Patients must have a tumor-related ECOG performance status of 0-2, which measures daily living abilities.
  • Patients should have an expected life expectancy of at least 12 weeks.
  • Creatinine clearance, a measure of kidney function, must be at least 30 ml/min.
  • Serum total bilirubin level, a measure of liver function, must be no more than 3 times the upper limit of normal.
  • ALT and AST, enzymes that indicate liver health, must be no more than 2.5 times the upper limit of normal, or 5 times if there are liver metastases.
  • White blood cell count must be at least 3.5 million/ml, neutrophil granulocytes count at least 1.5 million/ml, and platelet count at least 100 million/ml.
  • Pain must be controllable without using opioids, which are strong painkillers.
  • Patients must sign an informed consent form, agreeing to participate in the study and related research.
  • Patients must not be taking certain medications, including MAO-B inhibitors, strong inducers or inhibitors of CYP3A4, and certain heart medications that can affect heart rhythm.
  • Patients must be at least 18 years old.
  • There must be at least one measurable target lesion according to specific criteria, and it must not have been treated with radiation or other local treatments.

Who cannot join the trial?

9 criteria

  • Patients who do not have advanced, confirmed metastatic colorectal cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to understand or comply with the study requirements.
  • Patients who are pregnant or breastfeeding.
  • Patients with other serious health conditions that could interfere with the study.
  • Patients who have participated in another clinical trial recently.
  • Patients who are allergic to any of the study medications.
  • Patients who have a history of substance abuse or addiction.
  • Patients who are unable to provide informed consent.
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Investigated drugs

  • D,L-Methadone

    is a medication that is being tested in this trial to see if it can help treat advanced colorectal cancer. It is usually known for its use in pain management and as part of addiction treatment programs. In this study, researchers are looking at how it works when combined with another cancer treatment to see if it can help control the disease better.

  • mFOLFOX6

    is a combination of chemotherapy drugs that is commonly used to treat colorectal cancer. It includes several different medications that work together to stop cancer cells from growing and spreading. This treatment is already used in patients with colorectal cancer, and the trial is testing if adding D,L-Methadone can improve its effectiveness.

What is already known about the treatment

D,L-Methadone – D,L-Methadone is administered orally and is being studied in combination with a chemotherapy regimen called mFOLFOX6 for treating advanced colorectal cancer. Currently, it is in clinical trials to evaluate its safety and effectiveness when used with mFOLFOX6. The main therapeutic indication is for patients with advanced, metastatic colorectal carcinoma. At the molecular level, D,L-Methadone works by interacting with opioid receptors, which may help in managing pain and potentially enhancing the effects of chemotherapy. It is classified pharmacologically as an opioid analgesic.

Investigated diseases

Colorectal Carcinoma – Colorectal carcinoma is a type of cancer that begins in the colon or rectum, parts of the large intestine. It typically starts as a growth called a polyp on the inner lining of the colon or rectum, which can develop into cancer over time. As the disease progresses, cancer cells can invade and destroy normal tissue nearby and may spread to other parts of the body, a process known as metastasis. The progression of colorectal carcinoma can lead to symptoms such as changes in bowel habits, blood in the stool, abdominal discomfort, and unexplained weight loss. The disease is often categorized by stages, which describe the extent of cancer spread. Early detection and monitoring are crucial for managing the progression of this disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-519509-37-00Protocol codeAIO-KRK-0119Estimated enrolment84 patientsSponsorAIO-Studien gGmbH

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