Clinical Trial

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

Study acronym: MEFOX
Active, Not Recruiting Phase 1/2
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Record status
This record was last updated October 3, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
This is a phase I/II-trial with D,L-methadone and mFOLFOX6 in the treatment of patients with histologically confirmed chemo-refractory colorectal carcinoma. The aim of the phase-I trial is to evaluate the toxicity-profile and the dose-limiting toxicity of D,L-methadone combined with mFOLFOX6. Furthermore, to estimate the maximum tolerated dose and the recommended dose for phase-II-trial in the treatment of patients with histologically confirmed colorectal carcinoma not amenable to or progressing while having received all standard therapies. The primary endpoint of the randomized phase-II study is to determine the disease control rate 12 weeks after randomization of patients with histologically confirmed advanced colorectal carcinoma upon treatment with D,L methadone plus mFOLFOX6 versus mFOLFOX6 alone. Overall response rate according to RECIST1.1, progression free survival (PFS), overall survival (OS), quality of life (QoL) according to the EORTC QLQc30 questionnaire, patient-reported outcomes and safety will be evaluated as secondary objectives.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2022-01-23; most recent amendment 2025-09-30.
Status change: Recruiting → Active, Not Recruiting 2025-09-30
Status change: Not Yet Recruiting → Recruiting 2022-04-21
Trial Details
NCT Number NCT05212012
Lead Sponsor AIO-Studien-gGmbH
Collaborators: Deutsche Krebshilfe e.V., Bonn (Germany)
Conditions Chemo-refractory Colorectal Carcinoma
Enrollment 11 participants
Start Date 2022-02-17
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-10-03