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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

February 17, 2022

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
Chemo-refractory Colorectal Carcinoma
Interventions
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)

Trial Locations (3)

20246

Universitätsklinikum Hamburg Eppendorf - II. Med., Hamburg

73557

Stauferklinikum Schwäbisch Gmünd, Mutlangen

89081

Universitätsklinikum Ulm - Innere Med. I, Ulm

All Listed Sponsors
collaborator

Deutsche Krebshilfe e.V., Bonn (Germany)

OTHER

lead

AIO-Studien-gGmbH

OTHER