histologically confirmed, metastatic colorectal carcinoma, Patients with advanced
Conditions
Brief summary
Phase I: Evaluation of the toxicity-profile of D,L-methadone and the dose-limiting toxicity (DLT) in combination with mFOLFOX6 Estimation of the maximum tolerated dose (MTD) of D,L-methadone hydrochlorid in the combination with mFOLFOX6 Evaluation of the recommended dose for phase-II-trial (RPTD) of D,Lmethadone hydrochlorid, Phase II: Effect of mFOLFOX6 + D,L-methadone compared to mFOLFOX6 alone on disease control rate (DCR) defined as response (CR or PR) or stabilization (SD) of the tumor disease 12 weeks after randomization in ITT-analysis. DCR will be evaluated according to RECIST1.1 in patients with histologically confirmed chemorefractory colorectal carcinoma
Detailed description
Disease control rate 12 weeks after randomization (per-protocolpopulation), overall response rate according to RECIST 1.1, patientreported outcomes, PFS, overall survival, quality of life, safety, correlation of μ opioid receptor expression in tumor tissue and efficacy
Interventions
DRUGOXALIPLATIN
DRUGFOLINIC ACID
DRUGMethasan 10 mg/ml Konzentrat zur Herstellung einer Lösung zum Einnehmen.
DRUGFLUOROURACIL
Sponsors
AIO-Studien gGmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Evaluation of the toxicity-profile of D,L-methadone and the dose-limiting toxicity (DLT) in combination with mFOLFOX6 Estimation of the maximum tolerated dose (MTD) of D,L-methadone hydrochlorid in the combination with mFOLFOX6 Evaluation of the recommended dose for phase-II-trial (RPTD) of D,Lmethadone hydrochlorid, Phase II: Effect of mFOLFOX6 + D,L-methadone compared to mFOLFOX6 alone on disease control rate (DCR) defined as response (CR or PR) or stabilization (SD) of the tumor disease 12 weeks after randomization in ITT-analysis. DCR will be evaluated according to RECIST1.1 in patients with histologically confirmed chemorefractory colorectal carcinoma | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate 12 weeks after randomization (per-protocolpopulation), overall response rate according to RECIST 1.1, patientreported outcomes, PFS, overall survival, quality of life, safety, correlation of μ opioid receptor expression in tumor tissue and efficacy | — |
Countries
Germany
Outcome results
None listed