NCT05212012

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

A Phase I/II Trial of D,L-MEthadone and mFOLFOX6 in Treatment of Advanced Colorectal Cancer - The AIO-MEFOX Trial (AIO-KRK-0119)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: AIO-Studien-gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemo-refractory Colorectal Carcinoma

Interventions

Type	Name	Description
DRUG	Maximum tolerated dose, MTD: D,L-methadone hydrochloride (Methasan® 10 mg/ml)	Dose Level D,L-methadone hydrochloride (Methasan® 10 mg/ml) In dose level I a maximum of 30 mg/day (15 mg (1,5 ml) 1-0-1) In dose level II a maximum of 35 mg/ day (17.5 mg (1,75 ml) 1-0-1) In dose level III a maximum of 40 mg/day (20 mg (2,0 ml) 1-0-1)

Timeline

• Start date: 2022-02-17
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2022-01-27
• Last updated: 2025-10-03

Locations

3 sites across 1 country: Germany