Metastatic colorectal cancer MedDRA version: 20.0 Level: LLT Classification code 10052362 Term: Metastatic colorectal cancer System Organ Class: 100000016864
Conditions
Interventions
Product Name: Irinotecan
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: IRINOTECAN HYDROCHLORIDE
Other descriptive name: IRINOTECAN HYDROCHLORIDE
Product Name: Flouro
Sponsors
Klinikum der Ludwig-Maximilians Universität München, Klinikum Großhadern
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed adenocarcinoma of colon and rectum - confirmation of a K-RAS wild type status ( in the primary tumor or in metastasis) -stage IV - general condition: 0-2 (ECOG/ WHO) - suitable for application of chemotherapy - written informed consent (first and second-line therapy) - Age 18- 75 - clinical or ambulant treatment - Life expectancy > 3 months - minimum one measurable indicator leasion according to RECIST. Evaluation of tumor manifestation 2 weeks or less before study entry. - Male or female patients with reproductive potential must use an approved contraceptive method - Leucocytes = 3,0 x 10\9/L with Neutrophils = 1,5 x 10\9/L, Thrombocytes = 100 10\9/L, Hemoglobin = 5,6 mmol/L equivalent to 9 g/dL - Serum bilirubin = 1,5x upper NL - ALAT and ASAT = 2,5 x upper NL, in case of liver metastases ALAT and ASAT = 5 x upper NL. - Serum creatinine = 1,5 x upper NL - An operation has to take place 4 weeks before study entry; a fine needle biopsy must have been performed more than 1 week ago. Wounds must have completely healed. The necessity of a big operation in the course of the study is not to be expected. An exception is a resection of liver metastases. If there should be he option of a secondary curative operation Bevacizumab has to be discontinued 6 to 8 weeks before operation. - relevant toxicitys of therapies prior must have abate Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - confirmation of a K-RAS mutation - previous exposure to EGFR-targeting therapy - previous treatment with Bevacizumab - prior chemotherapy of colorectal cancer, except adjuvant chemotherapy wich was terminated at least 6 month before study entry - experimental medical treatment within 30 days before study entry - known hypersensitivity to elements of the study drug - pregnant (exclusion diagnosis by beta-hCG-test) or breast-feeding women - clinically relevant coronary disease or myocardial infarction within 12 months before study entry or enhanced risk of uncontrolled arrhythmia - acute or subacute intestinal obstruction or chronical-inflammatory enteritis during anamnesis or chronical diarrhea - symptomatic peritoneal carcinosis - serious, non-healing wounds, ulcera or bone fracture - uncontrolled hypertonia - pronounced proteinuria - arterial thromboembolism or haemorrhage within 6 months before study entry (except tumor bleeding before tumorresection) - hemorrhagic diathesis or thrombotic tendency - therapeutic anticoagulation (marcumar-therapy, PTT-effective heparinization) - known DPD-insufficience (special screening not necessary) - known glucuronisation defect (Gilbert´s disease) (special screening not necessary) - secondary malignancies during anamnesis within the last 5 years except curatively treated basalioma or in situ carcinoma of the cervix - known alcohol- or drug abuse - clinical or psychological disorders that would prohibit to give a valid informed consent or to perform the study - a significant concomitant disorder which excludes the patient´s participation in from the study in the opinion of the responsible physician - absent or constricted legal capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Comparative validation of antitumor efficacy measured by objective remissionrate defined by RECIST-criteria (OR= CR+ PR), assessed within intent-to-treat-collective.;Secondary Objective: Determination of progression free survival Determination of overall survival Rate of liver resection with potentially curative approach Evaluation of safety and compatibility (NCI-CTCAE-criteria) Determination of time to failure of strategy Determination of remission depth (maximum relative remission of tumor burden compared to baseline);Primary end point(s): Progression of metastatic colorectal cancer or patient's death | — |
Countries
Austria, Germany
Outcome results
None listed