The purpose of this study is to determine whether sorafenib in combination with chemotherapy has a positive effect on time to progression of the tumor or death for the treatment of large bowel cancer that has already progressed during a first chemotherapy.
Patients with metastatic CRC who received a first-line therapy with an Oxaliplatin- or Irinotecan based Fluoropyrimidine containing regimen ± bevacizumab and had a progression subsequently, are eligible for this study. Patients will be randomized to receive chemotherapy (FOLFOX6 or FOLFIRI) + sorafenib 400 mg bid or chemotherapy + placebo. Patients who have received an Oxaliplatin based Fluoropyrimidine containing regimen in first-line will obtain FOLFIRI during this study. Patients who have received an Irinotecan based Fluoropyrimidine containing regimen in first-line will obtain FOLFOX6. Primary objective of the study is to compare the Progression-free-survival (PFS) between patients receiving chemotherapy (FOLFOX6 or FOLFIRI) + sorafenib with chemotherapy + placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
101
To compare the PFS between patients receiving chemotherapy (FOLFOX6 or FOLFIRI) + sorafenib with chemotherapy + placebo
Time frame: 6 to 12 months
Disease control rate
Time frame: 6 to 12 months
Overall survival
Time frame: 6 to 12 months
Response rates
Time frame: 6 to 12 months
Safety
Time frame: signature of informed consent until 30 days after end of treatment
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400 mg/m2 intravenous infusion on day 1 of a 14-days cycle
400 mg/m2 intravenous bolus infusion on day 1, 2400 mg/m2 46 hour intravenous infusion on day 1 to 2 of a 14-days cycle
Ostalb-Klinikum Aalen, Medizinische Klinik 1
Aalen, Baden-Wurttemberg, Germany
Kreiskliniken Esslingen gGmbH, Klinik Nürtingen, Medizinische Klinik I
Nürtingen, Baden-Wurttemberg, Germany
Gemeinschaftspraxis Onkologie Ravensburg
Ravensburg, Baden-Wurttemberg, Germany
Gemeinschaftspraxis Dr. med. U. Banhardt, Dr. med. T. Fietz
Singen, Baden-Wurttemberg, Germany
Universitätsklinikum Ulm, Zentrum für Innere Medizin, Klinik für Innere Medizin I
Ulm, Baden-Wurttemberg, Germany
Medizinisches Versorgungszentrum am Siloah St. Trudpert Klinikum
Pforzheim, Baden-Würtemberg, Germany
Überörtliche Gemeinschaftspraxis Dres. Wilke und Wagner
Fürth, Bavaria, Germany
Hämatologischonkologische Schwerpunktpraxis
Herrsching am Ammersee, Bavaria, Germany
Hämatologie Onkologie Tagesklinik Landshut
Landshut, Bavaria, Germany
Hämato-Onkologische Schwerpunktpraxis Prof. Salat / Dr. Stoetzer / Prof. Hiller
München, Bavaria, Germany
...and 47 more locations