D,L-MEthadone and mFOLFOX6 in Treatment of Advanced Colorectal Cancer
Status:
Not yet recruiting
Trial end date:
2025-06-15
Target enrollment:
Participant gender:
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.