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

Study acronym: MEFOX
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 18 to confirmed 11 · Study sites: 2 to 3 · Primary and study completion dates: Jun 15, 2025 to Dec 2025v4 Show 3 more changesShow less
    • Enrollment target: estimated 18 to confirmed 11
    • Study sites: 2 to 3
    • Primary and study completion dates: Jun 15, 2025 to Dec 2025
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 2 · Start date changed from estimate of Feb 15, 2022 to Feb 17, 2022v2 Show 2 more changesShow less
    • Study sites: 0 to 2
    • Start date changed from estimate of Feb 15, 2022 to Feb 17, 2022
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov